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1/21
Regulatory Affairs
Professional Development
Framework
AN OVERVIEW
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2/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society
TABLE OF CONTENTS
Abstract.2
Introduction..2
Approach.3
Professional.Development.Framework.3
Proessional Levels ........................................................................................................................................3
Domains ........................................................................................................................................................4
Use.of.the.Framework.5
Regulatory.Affairs.Professional.Development.Framework.-.By.Level
Level I ...........................................................................................................................................................6
Level II ..........................................................................................................................................................8
Level III .......................................................................................................................................................11
Level IV .......................................................................................................................................................15
About.RAPS.1
2007 Regulatory Affairs Professionals Society. Any unauthorized copying or reproduction of all or a portion of this publication is strictly prohibited.
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3/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society
ABSTRACT
Proessions are characterized by several actors, including an identiable body o knowledge, a pathway or advancing
knowledge and skills related to the proession and an emphasis on continued learning and development. This paper
presents the Regulatory Aairs Proessionals Society (RAPS) Proessional Development Framework (PD Framework) or
the healthcare product regulatory aairs (RA) proession. The PD Framework oers a model or describing the basic
body o knowledge and relevant skills o the RA proession across product lines, geographic locations and employer
types at our major career stages. The ramework is the result o years o research and development carried out by
RAPS with the involvement o members worldwide. The studies results provide valuable insights into the nature o
the proession. The ramework denes the proession by proessional/career levels, domains that refect steps in thehealthcare product liecycle, the responsibilities and tasks o the RA proessional at each step and the associated
core knowledge and skills required o the proessional.
INTRODUCTION.
Regulatory aairs (RA) proessionals play critical roles throughout the healthcare product liecycle, rom concept
through product obsolescence. They provide strategic, tactical and operational direction and support or working within
regulations to expedite the development and delivery o sae and eective healthcare products to individuals around
the world. Continuous evolution in science and changes in the regulatory environment, health sector and general
economics shape the dynamic and expanding scope o the regulatory aairs proessional. RA proessionals must
continually grow their knowledge and skills to be eective and to advance in their proession.
The Regulatory Aairs Proessionals Society (RAPS) was established in 1976 with a mission o creating the oundationor developing and nurturing the emerging healthcare product regulatory aairs proession. A key building block o
establishing RA as a proession was put into place in 1990 when RAPS introduced a proessional certication, the
Regulatory Aairs Certication (RAC). The development o the RAC was based upon extensive research on the scope
o practice and specic activities o the proessional with three to ve years o regulatory experience, the target or
this proessional credential. This research has been replicated and updated several times, with studies extended to
proessionals involved with the European, US and Canadian regulatory systems.
The role delineation research indicated the unique knowledge base o the proession, which extends through the
healthcare product liecycle and blends content rom the sciences, law and business. These studies also indicated
consistency in the general scope o responsibilities o the proessionals at this level, distinct rom geographic location
However, these studies ocused on only one level o the proession.
The RA proession today encompasses multiple levels, rom the proessional at entry level through the highly
experienced proessional with extensive technical knowledge and management responsibilities. RAPS ongoingresearch on the scope o practice o RA proessionals1 indicates changes in their specic responsibilities and
activities at dierent stages o their careers. However, these studies are not designed to collect detailed inormation
about specic responsibilities or the knowledge and skills needed to successully undertake these activities. Instead,
RAPS considers this inormation vital to its role o supporting and advancing the RA proession and to providing the
basis or relevant continuing education and proessional development. Consequently, RAPS initiated a multi-year role
delineation-type research eort to develop a ramework or describing the scope o practice and responsibilities o
the RA proessional at dierent career stages and associated knowledge and skills. This initiative resulted in the
Proessional Development Framework (PD Framework).
The PD Framework provides a general model or describing the RA proession at the our career stages delineated in
this project. For each level, the ramework presents tasks and responsibilities organized according to the stages and
steps in the healthcare product liecycle (see.Figure.1), as well as the associated knowledge and skills required by
the proessional.
The research and development o the ramework were undertaken to ensure it applies to proessionals in industry,
government, research and clinical settings, and is not product-specic. Further, the ramework is not based upon
specic regulatory systems or geography. The ramework is not intended to provide all the details o the scope o
practice or responsibilities o regulatory proessionals. Nor is it intended to be a prescriptive description o the required
knowledge, skills or competencies o the proessional. However, the ramework does provide a oundation rom which
we can describe the evolution o proessionals in their careers and develop guides or proessional development.
1 RAPS undertakes biennial studies on the general scope o practice and compensation o RA proessionals in the US, Canada and European Union.
These studies oer general trends in scope o practice by position/title, regulatory experience, employer and other actors but are not designed to
collect more detailed inormation about specic roles and responsibilities.
Additional levels may be dened in uture updates to this ongoing RAPS initiative.
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APPROACH
The approach to developing the PD Framework was adapted rom the detailed role delineation studies (job analyses)
used to develop proessional certication examinations, including the RAC. The early stages o this project were
guided by a psychometrician with extensive experience in research and proessional certication who also advised the
RAC program.
From 003 through 007, RAPS members served as advisors on multiple special task orces created to undertake this
initiative. The task orces consisted o senior regulatory proessionals representing diversity in product responsibility,
proessional responsibility, company structure and geographic responsibility. The task orces developed comprehensive
outlines o the scope o RA proessional practice and associated knowledge and skills or proessionals at designated
career stages: new; midlevel (approximately ve to 10 years o proessional experience); and senior/executive level.
The detailed outlines were validated through comprehensive surveys ollowed by a series o ocus groups. More than
500 regulatory proessionals were involved in the development and validation processes over a two-year period. The
outlines or the proessional with three to ve years o experience (the RAC level) were adapted rom data rom the RA
role delineation studies. Findings were analyzed and reviewed by the original task orce and then by a newly appointed
global task orce that also reviewed the nal model and accompanying materials.
PROFESSIONAL.DEVELOPMENT.FRAMEWORK
The PD Framework is based on two primary dimensions: Level, reerring to one o our proessional/career levels
and Domains, which refect scope o responsibilities throughout the product liecycle. The levels and domains are
organized within the ramework by premarket and postmarket stages o product development, strategic planning and
interacing activities. For each level and domain, the PD Framework presents major BasicKnowledge (proessional),
Skills/Abilities (proessional and interpersonal/business-related), and Institutional Knowledge.
PROFESSIONAL.LEVELSThe PD Framework currently describes the RA proession at our stages. While the development o the ramework did
not attempt to assign job titles to specic levels, examples o relevant titles are included in the summaries below.
Figure.1
RA Profession: Integral to the Healthcare Product Lifecycle
2007 Regulatory Aairs Proessionals Society
Premarketing
PostmarketingInterfacing
Strategic
Planning
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Level.I
These individuals are new or relatively new to the proession with limited or no regulatory aairs knowledge. Many
have education and/or experience in science, clinical studies or engineering and understand specic aspects o the
healthcare product arena. Throughout Level I, these individuals develop basic knowledge and understanding o the
regulatory and legal rameworks, regulatory requirements, legislation, processes and procedures.
Level I proessionals should possess skills such as project management, writing, coordination, and interpersonal and
communication skills. A science background and basic statistical knowledge are advantages. At this level, individuals
coordinate and support technical and scientic regulatory activities. There is less ocus on technical skills and more
ocus on project coordination and support. (Example job titles: coordinator and some associate positions)
Level.II
Level II proessionals develop and expand upon an integrated understanding o regulatory aairs as it applies
throughout the product liecycle. There is a strong emphasis on technical aspects o the proession, combined with
scientic understanding and strong project management. Level II proessionals oten expand their involvement in
international/multinational regulatory issues and begin more active involvement with concepts o regulatory strategy.
They perorm technical and scientic regulatory activities.
At Level II, individuals demonstrate knowledge and skills in areas such as, but not limited to, regulatory pathways and
options; documentation; risk-benet analysis; communication and collaboration internally and externally; working with
vendors and subcontractors; submission, registration, obtaining approval, documentation, compliance, postmarketing
surveillance/vigilance; and distribution. These individuals ocus on hands-on training to strengthen and develop new
skills and knowledge.
Regulatory Aairs Certication is targeted to proessionals at this level. (Example job titles: some associate positions,
specialist, and some assistant manager and manager positions)
Level.III
Level III proessionals integrate regulatory knowledge throughout the product liecycle with aspects o eective
management and strategy development. This level represents the move rom the technical and tactical dimensions o
RA and the product liecycle into a more strategic role.
Individuals at this level have strong technical and management skills and are actively engaged in regulatory strategy
and operations. They are oten engaged in activities spanning the product liecycle and are involved in business/
organizational activities, management and strategy. Level III proessionals demonstrate skills and knowledge in areas
such as, but not limited to: strategy development, risk assessment and management; monitoring and communicating
change in the regulatory environment as well as global communication; sta and vendor development and
management; and infuencing the regulatory environment. (Example job titles: manager, associate director, director)
Level.IV
Level IV proessionals are strategic and innovative. They assume a strategic lead role representing the regulatory
perspective while proactively developing new and oten innovative approaches or pursuing business objectives within
the regulatory ramework. Some o the most important acets o the Level IV proessionals scope o practice are
responsibilities and tasks related to strategic planning and interacing throughout the product liecycle, both within the
organization and with diverse external groups.
Based upon a strong and extensive understanding o the role o the proession in the product liecycle and the
dynamics o regulatory processes, these proessionals are also engaged in policy development within their
organizations and with external groups. They typically are leaders and mentors within their organization and or the
proession. At Level IV, proessionals must be able to work eectively in multinational/multicultural environments.
(Example job titles: may include directors in some organizations, vice president, executive director, chie regulatory ofcer)
DOMAINS
Domains represent the major content categories within each level o the PD Framework. The our domains are
organized to encompass major tasks and responsibilities o the RA proessional throughout the product liecycle.
The PD Framework domains are:
Strategic planning: encompassing regulatory strategy throughout the liecycle; access to and organization oregulatory inormation and knowledge; integration o regulatory perspectives into the organization; and regulatory
policies and procedures. At Levels II I and IV, this domain also includes integration o regulatory strategy and policy
into overall organizational approaches. Responsibilities described under this domain apply throughout the liecycle.Premarketing: encompassing research and development; and preclinical and clinical phases through submission/registration.
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Postmarketing: encompassing reporting, compliance and postmarket surveillance; inspections; labeling; advertisingand promotion; and sales-related responsibilities.Interacing: responsibilities extending throughout the liecycle, encompassing communication and interaction withinthe organization; with regulatory agencies, and proessional trade and standards organizations; and with other
stakeholders.
Responsibilities and tasks listed under each domain represent the major activities reported by RA proessionals at each
level. It is important to note that some responsibilities/tasks apply to multiple phases in the product liecycle, even i
they are listed under one domain. Further, the responsibilities and tasks described may not ully capture the activities
o each RA proessional. The nature o the organization, the education and previous experience o the proessional andother actors may de-emphasize some responsibilities listed in the ramework and/or add tasks and responsibilities.
The ramework summarizes the knowledge, skills and abilities o the RA proessional at each level by domain. Many
acets o knowledge and skills apply to all proessional levels. Generally, during early proessional stages (Levels I and
II), the RA proessional builds a solid understanding o regulations, regulatory processes and procedures throughout
the liecycle. The applications o this knowledge and the skills at these levels are typically tactical. At Levels III and IV,
RA proessionals build on their knowledge and skill base, adding increasing strategic and management qualications.
Proessionals at these levels are oten less-ocused on tactical elements o regulatory aairs and more engaged in
broad-scale, strategic perspectives.
USE.OF.THE.FRAMEWORK
The PD Framework is intended as a basic guide to the scope o practice and evolution o the RA proessional. Theramework provides an outline o the responsibilities, knowledge and skills o the proessional at our stages o
proessional development. As such, the ramework oers a tool or career/proessional development planning by the
individual proessional, the regulatory manager and mentor, and by organizations.
The ramework is not intended to be detailed or precisely tailored to the specic structure, product ocus or nature
o every organization. Thus, individuals and organizations should use it as a basic oundation, rening its content
with additional details relevant to the individual and organization. The PD Framework is also an important tool or
developing continuing education plans.
Additional tools and approaches or customizing and rening the PD Framework are available rom RAPS.
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RA.PROFESSIONAL.DEVELOPMENT.FRAMEWORK.-.LEVEL.I
Level I proessionals typically are new to regulatory aairs. Many have scientic, clinical or engineering backgrounds and
understand specic aspects o the healthcare product arena. These proessionals should possess project management, writing,
interpersonal and communication skills, among others.
Knowledge,SkillsandAbilities
ThroughouttheProductLifecycle
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Ethics and product liecycle
Standard operating procedures(SOPs)
Product history, prole,
specications, standards,
saety issues, reimbursement,
precedents and approval
Regulatory history, guidelines,
policies, standards, practices,
requirements and precedents
Regulatory agency structure,
processes and key personnel
Principles and requirements o
ood and drug laws
International treaties and
regional, national, local and
territorial trade requirements,
agreements and considerations
Apply business and RA ethical
standardsThink analytically and critically
Communicate eectively
verbally and in writing
Work with cross-unctional
teams
Review and analyze
documentation
Write and edit technical
documents
Meet deadlines
Handle detailed tasks and
prioritize them
Manage projects
Company SOPs
Department SOPsCompany history, philosophy,
culture, policies, processes,
goals, code o ethics and
position
StrategicPlanning
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Assist in SOP development and
review
Stay abreast o regulatory
procedures and changes in
regulatory climate
Maintain records on legislation,
regulations and guidelines
Investigate regulatory history
o similar products to assess
approval implications
Conduct research on
submission requirements and
options
Assist in monitoring andreporting project timelines
Respond to RA inormation
requests
Monitor and utilize tracking and
control systems
Medical terminology
Regulatory terminology
Domestic regulatory markets
International regulatory markets
Submission types and
requirements
Research and locate
inormation on regulatory
requirements and similar
products
Key company contacts
Premarke
ting
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Organize materials rom
preclinical and clinical studies
or review and assist in review
process
Compile and organize materials
or presubmission reports
Coordinate and assist in the
preparation o submission
packages or regulatoryagencies
Implement submission
templates
Oversee quality control o
regulatory documents and
submissions
Monitor applications under
regulatory review
Maintain regulatory les
Organize meetings with
regulatory agency sta
GxPs (GCPs, GLPs, GMPs)
Electronic submission
techniques, types and
requirements
Clinical research, clinical
operations, nonclinical and
quality requirements
Company inormation
management systems
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Postmar
keting
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Update and maintain paper/
electronic document archival
systems
Assist in the preparation o
routine reports and regulatory
agency communications
Assist in the review o public
communication or regulatory
perspectivesAssist in the review o
advertising and promotional
items
Coordinate internal audits and
inspections
Assist in the preparation
o postmarket reports and
submissions
Track product events,
complaints and recalls
GxPs (GCPs, GLPs, GMPs)
Approval status in other
markets
Principles and requirements
o promotion, advertising and
labeling
Submission types and
requirements
Import/export requirements
Company inormation
management systems
Interfacing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Provide inormation on
regulatory requirements to other
departments and/or business
unitsParticipate in product and/or
regulatory teams to coordinate
documentation
Maintain records to comply with
regulatory requirements
Compose routine
correspondence to regulatory
agencies
Interact with outside experts,
partners and regulatory
agencies, as requested
Assist in preparing or technical
meetings with regulatory
agencies
Principles and requirements
o promotion, advertising and
labeling
Submission types andrequirements
Analyze relevant data and
inormation
Key company contacts
Internal inspection procedures
Communication routes
RA Professional Development Framework - Level I (cont.)
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RA.PROFESSIONAL.DEVELOPMENT.FRAMEWORK.-.LEVEL.II
Level II proessionals develop an understanding o regulatory aairs throughout the product liecycle. There is a strong emphasis on technical
aspects o the proession, scientifc understanding and project management. These proessionals oten expand their involvement with
international/multinational regulatory perspectives and begin more active involvement with regulatory strategy.
Knowledge,SkillsandAbilities
ThroughouttheProductLifecycle
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Track and keep records
Manage internal reviewprocesses
Communicate with scientic
and regulatory personnel
International treaties and
regional, national, local andterritorial trade requirements,
agreements and considerations
Domestic and international
regulatory guidelines, policies
and regulations
Product proles, specications,
standards and history
Regulatory history, guidelines,
policies, standards, practices,
requirements and precedents
specic to the product
Standard operating procedures
(SOPs)
Regulatory agency structure,
processes and key personnel
Ethical guidelines o the RAproession, clinical research
and regulatory process
Apply business and RA ethical
standardsCommunicate with diverse
audiences and personnel
Work with cross-unctional
teams
Write and edit technical
documents
Think analytically
Manage projects
Create project plans and
timelines
Organize and track complex
inormation
Negotiate internally and
externally with regulatory
agencies
Company history, philosophy,
culture, policies, processes,goals, code o ethics and
position
Department SOPs
Company SOPs
StrategicPlanning
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Assist in SOP development and
review
Assist in the development o
regulatory strategy and update
strategy based upon regulatory
changes
Provide regulatory input to
product liecycle planning
Evaluate regulatory impact on
proposed products
Understand, investigate and
evaluate regulatory history/background o class, disease/
therapeutic/diagnostic context
in order to assess regulatory
implications or approval
Determine trade issues to
anticipate regulatory obstacles
Determine and communicate
submission and approval
requirements
Participate in risk-benet
analysis or regulatory
compliance
Continue to revisit and compare
regulatory outcomes with initial
product concepts to make
recommendations on utureactions
Research methods
External regulatory environment
aecting the industry
Fundamental processes,
standards and practices or
regulatory approval
Dierences in legislative
authorities
Needs/impact analysis
Liecycle planning and
management
Communicate and network
with scientic and regulatory
personnel to obtain relevant
inormation
Translate and communicate
technical regulatory issues or
nontechnical audiences
Research, analyze, integrate
and organize background
inormation rom diverse
sources
Assess and interpret regulatoryrequirements and their impact
Communicate clear and
balanced evaluations
Perorm due diligence
Apply risk-benet analysis
techniques
Assess products market
viability
Key company contacts
Present and uture competitive
landscape o similar products
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Premarketing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Advise responsible personnel
on regulatory requirements or
quality, preclinical and clinical
data requirements or clinical
study applications or marketing
applications
Evaluate proposed preclinical,
clinical and manuacturing
changes or regulatory lingstrategies
Assess the acceptability o
quality, preclinical and clinical
documentation or submission
ling to comply with regulatory
requirements or clinical trials,
marketing applications and
corporate goals, to secure
submission approval
Coordinate and execute
preapproval compliance
activities
Monitor impact o changing
regulations on submission
strategies
Identiy issues early in thesubmission preparation process
that could impact product
launch
Compile, prepare, review and
submit regulatory submission to
authorities
Monitor and submit applicable
reports and ensure appropriate
responses are submitted to
regulatory authorities
Negotiate and interact with
regulatory authorities during
the development and review
process to ensure submission
approval
Submission types and
requirements
Electronic submission
requirements
Clinical research, clinical
operations and nonclinical and
quality regulatory requirements
Appeals processes
GxPs (GCPs, GLPs, GMPs)
Communicate with internal
stakeholders and regulatory
authorities
Write, review and prepare
complex documents
Prepare applications and
regulatory documentation
Review acceptability o
quality, preclinical and clinicaldocumentation and data,
statistical methods and analysis
Review and assess regulatory
submissions
Utilize electronic submission
techniques
Assess the regulatory impact on
ling strategies
Apply risk-benet analysis
techniques
Key company contacts
RA Professional Development Framework - Level II (cont.)
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Postmarketing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Maintain annual licenses,registrations, listings and patent
inormationReview regulatory aspects o
contractsEnsure compliance with
product postmarketing approvalrequirements
Approve advertising and
promotional items orcompliance beore releaseGenerate and approve labeling
or compliance beore releaseReview publicly disseminated
inormation to minimizeregulatory exposure, review
product claims and preservecondentiality o applicable
product inormationProvide regulatory input or
and appropriate ollow-up toinspections and audits
Assist in the development andimplementation o SOPs and
systems to track and manageproduct-associated events
Submit and review changecontrols to determine the levelo change and consequent
submission requirementsContribute to the development
and unctioning o the crisis/issue management program
Participate in ensuringadequacy o product
traceability systemsIdentiy product-associated
problems and developproposals or solutions
Ensure product saety issuesand product-associated events
are reported to regulatoryagencies
Provide regulatory input or
product recalls and recallcommunications
GxP (especially GMP) quality
systems
Advertising and promotional
approaches and related
regulatory perspectives
Risk management
Manuacturing processes
Quality systems
Product labeling issues
Product registration and patent
requirements
Work in diversied team
environments to leverage a
broad viewpoint on problem
resolution
Plan training and education or
a variety o stakeholders
Manage access to inormation
requests
Write competitive statements
that are clear, accurate and
supported by the data
Interpret regulations, advertising
messages and data to ensure
consistency with approved
labeling
Review marketing and
promotional materials
Edit public messages to ensure
compliance with regulatory
practice
Write and review product labels
Write and review reports and
ollow-up communication with
regulatory agencies
Develop objective analyses or
management
Evaluate options and
recommend viable solutions to
management
Communicate deciencies
to discipline experts (e.g.,
medical, legal, corporate)
Write internal correspondence
that describes SOP gaps or
deciencies
Edit contract texts to accurately
convey inormation pertaining to
delegated regulatory activities
Apply crisis assessment
techniques
Company inormation
management systems
Interfa
cing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Provide training or sta on
current and new regulatory
requirements
Communicate regulatory
agency/industry positions
within the regulatory
department
Problem-solve with and advise
internal stakeholders on
regulatory issues
Communicate and negotiate
with regulatory authorities and
stakeholders
Conduct and participate
in technical meetings with
regulatory advisory committees
and agencies
Accompany inspection team(s)
as required
Notiy, consult or brie legal
counsel when appropriate
Identiy standards or the
organizations products
Participate in proessional
associations, industry/trade
groups ( local/regional/
international) and appropriate
standards organizations
Principles o team dynamics
Inspection authority and
requirements
Role o proessional, trade and
standards organizations
Standards development
Network with internal/external
colleagues
Build teams
Negotiate industry and
regulatory positions
Organize meetings
Develop and deliver technical
presentations
Communicate proposed
regulations to internal
stakeholders
Communicate regulatory
requirements to scientic/
medical/technical experts
Analyze regulatory requirements
and their implications
Identiy regulatory problems
Apply risk-benet analysis
techniques
Interpret regulatory impact on
the company
Internal inspection procedures
Internal routes o
communication
RA Professional Development Framework - Level II (cont.)
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RA.PROFESSIONAL.DEVELOPMENT.FRAMEWORK.-.LEVEL.III
Level III proessionals integrate regulatory knowledge throughout the product liecycle with aspects o eective management and strategy
development. This level represents the move rom the technical and tactical dimensions o RA and the product liecycle into a more strategic role.
Knowledge,SkillsandAb
ilities
ThroughouttheProductLi
fecycle
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
International treaties and
regional, national, local and
territorial trade requirements,agreements and considerations
Apply ethical standards
Perorm risk assessment
Plan and conduct meetingsManage projects
Company history, philosophy,
culture, policies, processes,
goals, code o ethics andposition
StrategicPlannin
g
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Evaluate regulatory ri sks o
corporate policies
Recruit, manage, develop and
mentor regulatory proessionals
Develop new regulatory policies,
procedures and SOPs and train
key personnel on them
Assist in the development and
advancement o policy and
procedures or regulatory aairs
and compliance to establish
a compliant culture within the
organization
Utilize technical regulatory
skills to propose strategies on
complex issues
Monitor emerging issues and
identiy solutions
Monitor trade association
positions or impact on
company products
Provide regulatory input to
product liecycle planning
Anticipate regulatory obstacles
and emerging issues throughout
the product liecycle and
develop solutions with other
members o regulatory and
related teams
Evaluate the eect o regulatory
requirements on product
positions
Assist in the development
o global, regional and
multicountry regulatory strategy
and update strategy based
upon regulatory changes
Determine submission and
approval requirements
Monitor regulatory outcomes
o initial product concepts
and provide input to senior
regulatory management
Assist in regulatory due
diligence
Domestic regulatory markets
International regulatory markets
Due diligence process
Regulatory intelligence,
acquisitions and partnerships
and internal or external license
opportunities
External regulatory environment
aecting the industry
Assess regulatory impact and
risk
Compile and synthesize relevant
data to complete regulatory
submissions
Key company contacts
Department SOPs
Company SOPs
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Premarketing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Provide strategic input
and technical guidance on
regulatory requirements to
development teams
Evaluate risk o and regulatory
solutions to product and
clinical saety issues during
clinical phases and recommend
solutionsEvaluate proposed preclinical,
clinical and manuacturing
changes or regulatory ling
strategies
Manage and execute
preapproval compliance
activities
Assess the acceptability o
quality, preclinical and clinical
documentation or submission
ling
Negotiate and interact with
regulatory authorities during
the development and review
process to ensure submission
approvalIdentiy issues early in the
submission preparation process
that could impact product
launch
Monitor impact o changing
regulations on submission
strategies and update internal
stakeholders
Prepare regulatory submissions
Monitor and submit applicable
reports and responses to
regulatory authorities
Monitor applications under
regulatory review
Propose risk-based decisions
on special access approval withappropriate regulatory agencies
to pursue approvals based
on patient needs and risk
assessment
Specic requirements or
preclinical data relevant to the
product
Clinical trial design
Statistics
Quality standards specic to
the product
GxPs (GCPs, GLPs, GMPs)
Therapeutic regulatoryprecedents and applications o
products
Submission requirement
processes
Electronic submission process
Risk-benet assessment
methodology
Regulatory agency inspection
and compliance policies
Appeals processes
Prior agreements with regulatory
agencies on product or related
products, regulatory precedents,
prospects
Limitations o regulatory
authorityGlobal saety reporting
requirements
Present and uture competitive
landscape o similar products
Determine product regulatory
path or class
Dene data to support product
claims
Interpret and evaluate data
Review regulatory submissions
Approve regulatory ling
strategies based upon
proposed preclinical, clinicaland manuacturing changes
Assess regulatory impact and
risk
Develop regulatory and
registration plans with specic
deliverables and timelines
Integrate business and clinical
objectives with regulatory
requirements
Advise stakeholders o
regulatory options and status
Work with regulators and
provide eedback to them
Implement processes to ensure
compliance
Company business objectives
and claims o product and
marketing environment
RA Professional Development Framework - Level III (cont.)
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14/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society
Postmarketing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Maintain annual licenses,
registrations, listings and patent
inormation
Ensure compliance with
product postmarketing approval
requirements
Review and approve labeling
to ensure compliance with
regulations and company policyReview and approve advertising
and promotional items to
ensure regulatory compliance
Assess external
communications relative to
regulations
Review publicly disseminated
inormation to minimize
regulatory exposure, review
product claims and preserve
condentiality o applicable
product inormation
Review and approve required
reports, supplemental
submissions and other
postmarketing commitments toupdate and maintain product
approvals and registrations
Provide regulatory input or
and appropriate ollow-up to
inspections and audits
Develop, implement and
manage appropriate SOPs and
systems to track and manage
product-associated events
Submit/review change controls
to determine the level o change
and consequent submission
requirements
Actively contribute to the
development and unctioning
o the crisis/issue managementprogram
Identiy product-associated
problems and develop
proposals or solutions
Provide regulatory input or
product recalls and recall
communications
Manage system to ensure that
product saety issues and
product-associated events are
reported to regulatory agencies
Report adverse events to
regulatory agencies and internal
stakeholders
Generate timely, complete and
accurate updates
Select and use appropriate
inormation systems
Interpret regulatory
requirements and guidelines
Identiy condential and
proprietary inormation
Apply risk-assessmenttechniques
Assess need or postmarketing
submissions
Review and approve inspection
and audit communications
Recommend corrective actions
to management
Negotiate with regulatory
agencies
Address saety issues while
maintaining commercial
viability o product
Strategize processes or
marketing products and crating
product claims
Manage access to inormationrequests
Evaluate options and
recommend viable solutions to
management
Company history, philosophy,
culture, policies, processes,
goals, code o ethics and
position
Company inormation
management systems
RA Professional Development Framework - Level III (cont.)
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15/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society
Interfacing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Provide training or stakeholders
on current and new regulatory
requirements to ensure
company-wide compliance
Communicate regulatory
agency/industry positions to
internal stakeholders
Strategize with and advise
internal stakeholders onregulatory issues
Communicate and negotiate
with regulatory authorities and
stakeholders
Conduct technical meetings
with regulatory advisory
committees and government
agencies
Communicate the impact o
new, existing and pending
regulations, guidelines
and standards, and review
committee recommendations
to regulatory sta and internal
stakeholders
Participate in medical/scienticreview and other relevant
committees
Accompany inspection team(s)
as required
Notiy, consult or brie legal
counsel when appropriate
Participate and take
leadership role in proessional
associations, industry/trade
groups (local/regional/
international) and appropriate
standards organizations
Regulatory agency and
stakeholder decision makers
o the regulatory agency and
stakeholders
Structure o the regulatory
agency(s)
Principles o regulatory
compliance
External communication routesDue diligence process
Product proles
Risk-benet assessment
methodology
Legal ramework and potential
actions
Dierences in legislative
authorities
Process to develop new
legislation and regulation
Developing, pending and recent
legislation, regulations and
guidelines
Inspection authority and
process
Standards organizations andstandards development process
Reimbursement process and
requirements
Current scientic trends
Competitive environment
Current issues acing industry
Work eectively across dierent
cultures and languages
Communicate with scientic,
technical, business and public
organizations
Present complex inormation
Translate regulatory language
into meaningul business terms
Synthesize applicable datarequirements
Analyze regulatory requirements
and their implications
Assess compliance in technical
presentations
Apply risk-benet analysis
techniques
Identiy regulatory and legal
impact on organization
Manage inspections and audits
Key company contacts
Internal communication routes
Internal inspection procedures
Training requirements
RA Professional Development Framework - Level III (cont.)
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16/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society
RA.PROFESSIONAL.DEVELOPMENT.FRAMEWORK.-.LEVEL.IV
Level IV proessionals assume the strategic lead representing the regulatory perspective while developing new approaches or business
objectives. Strategic planning and interacing throughout the product liecycle, both within and external to the organization, are among the most
important responsibilities. These proessionals must be able to work eectively in multinational/multicultural environments.
Knowledge,SkillsandAbi
lities
ThroughouttheProductLifecycle Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Assign and manage unctional
groups in the development orelevant data to complete a
regulatory submission
Product prole, specications,
standards and historyRegulatory history, guidelines,
policies, standards, practices,
requirements and precedents
specic to the product
Regulatory agency structure,
processes and key personnel
International treaties and
regional, national, local and
territorial trade requirements,
agreements and considerations
Apply business and RA ethical
standardsPlan and conduct meetings
Manage projects and teams
Company history, philosophy,
culture, policies, processes,goals, code o ethics and
position
StrategicPlanning
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Participate in developing/
updating organizational code
o ethics
Recruit, develop, manage andmentor regulatory proessionals
to contribute to organizational/
human capital planning
Provide strategic guidance or
resource and development
planning
Assess emerging issues and
develop solutions to them
Develop solutions to address
issues with other members o
management and stakeholders
Develop corporate positions on
regulatory risk-benet
Identiy need or new regulatory
policies, procedures and SOPs
and approve them
Develop and advance theorganizations policy and
procedures or regulatory aairs
and compliance to establish a
compliant culture
Develop strategies or
complex issues with potential
or signicant regulatory
compliance impact
Anticipate regulatory and
related obstacles and emerging
issues throughout the product
liecycle
Provide strategic guidance
or product development
and planning throughout the
product liecycle
Create and develop productpositioning strategies based
upon regulatory requirements
Integrate regulatory
considerations into the
corporations global product
entry and exit strategy
Analyze and compare regulatory
outcomes with initial product
concepts and recommend
uture strategies and actions
Develop global, regional
and multicountry regulatory
strategies and update based
upon regulatory changes
Key company contacts
Routes o communication
Research and development
methodsNeeds/impact analysis
Due diligence process
Dierences in legislative
authorities
Fundamental processes,
standards and practices or
regulatory approval
Regulatory requirements
applied throughout the
liecycle to meet regulatory and
reimbursement requirements
and business objectives
Domestic and international
regulatory guidelines, policies
and regulations
External regulatory environmentaecting the industry
Strategic planning, business
processes, project management
Think analytically
Understand good management
practices
Collaborate across unctionalgroups
Establish and maintain
relationships with regulatory
personnel
Communicate eectively with
diverse audiences
Translate technical regulatory
issues into understandable
language
Integrate inormation rom
diverse sources
Develop SOPs
Apply risk-benet analysis
techniques
Perorm due diligence
Anticipate issues or obstaclesimposed by regulatory
requirements
Analyze regulatory guidelines,
policies and actions to
determine regulatory and legal
impact on the company
Assess regulatory impact
and risk, and make risk
management recommendations
Create and manage strategic
and project plans
Assess market viability o
products
Develop multinational/global
strategies
Present and uture competitive
landscape o similar products
Key company contacts
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Premarketing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Provide strategic input on
regulatory requirements to
development teams
Evaluate risk and saety issues
and recommend regulatory
solutions during clinical phases
Manage preapproval
compliance activities
Negotiate with regulatoryauthorities during the
development and review
process to ensure submission
approval
Formulate company procedures
to respond to regulatory
authority queries
Identiy and address issues
early in the submission that
could impact the product
launch preparation process
Communicate application
progress to internal
stakeholders
Approve regulatory ling
strategies based uponproposed preclinical, clinical
and manuacturing changes
Make risk-based decisions on
special access approvals based
upon patient needs and risk
assessment
All o the above
Regulatory agency inspection
and compliance policies
Risk-benet assessment
methodology
Present and uture competitive
landscape o similar products
Company business objectives,
product claims and marketingenvironment
Submission requirement
processes
Electronic submission process
Therapeutic regulatory
precedents and applications o
products
Quality standards specic to
the product
Specic requirements or
preclinical data relevant to the
product
Clinical trial design
Statistics
GxPs (GCPs, GLPs, GMPs)
Prior agreements with regulatoryagencies on the product or
related products; regulatory
precedents and prospects
Appeals processes
Limitations o regulatory
authority
Global saety reporting
requirements
Advise stakeholders o
regulatory options and
recommend solutions
Strategize processes or
marketing products and crating
product claims
Assess regulatory impact and
risk
Select and implement systemsto ensure compliance
Review regulatory submissions
Dene data to support product
claims
Create and implement crisis
management plans and
procedures
Develop optimal submission
strategy and plans
Edit submissions to regulatory
agencies
Articulate strategy rationale
Strategize processes or
marketing products and crating
product claims in collaboration
with internal s takeholdersIntegrate business and clinical
objectives with regulatory
requirements
Formulate creative solutions
that address issues and meet
requirements and clinical and
business goals
Monitor product development in
other jurisdictions
Lead team in articulating
science-based rationale to
support companys response
Communicate complex
technical inormation to
nontechnical audiences verbally
and in writing
Present and uture competitive
landscape o similar products
RA Professional Development Framework - Level IV (cont.)
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18/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society
Postmarketing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Manage processes and
personnel involved with
maintaining annual licenses,
registrations, listings and patent
inormation
Ensure compliance with product
postmarketing requirements
Review and approve required
reports and supplementalsubmissions
Review and approve advertising
and promotional items or
regulatory compliance
Review and approve labeling to
ensure compliance
Review and approve publicly
disseminated inormation to
minimize regulatory exposure;
review product claims, and
preserve condentiality o
applicable product inormation
Oversee regulatory aspects
o business relationships to
ensure compliance and protect
corporate interestsEnsure a system is in place to
manage access to inormation
requests
Develop, implement and
manage SOPs and systems to
track and manage product-
associated events
Review change controls or
level o change and consequent
regulatory notication
Provide regulatory input or
ollow-up to inspections and
audits to minimize potential or
ndings o noncompliance
Lead crisis management
program development andimplementation
Identiy and present option or
risk mitigation to decision-
makers
Develop a system to ensure
product saety issues and
product-associated events are
reported to regulatory agencies
Report adverse events (AEs)
Represent regulatory aairs
in product recall and recall
communication process
Crisis management techniques
AER requirements and
processes
Domestic and international
regulatory markets
Limitations and strengths
o various types o market
interventions
GxPs (GCPs, GLPs, GMPs)Business strategy
Risk management techniques
Inormation technology as
applied to product distribution
Various market intervention
limitations and strengths
Patterns o potential o-label
product uses
Patterns o product misuse and
abuse
Reimbursement approval
requirements
Inormation, knowledge
management and tracking
systems
Product distribution issues
Assess nature and degree o
product status change relative
to listed regulatory criteria
to compile cor responding
submission
Assess need or postmarketing
submissions
Select and use appropriate
inormation systemsGenerate timely, complete and
accurate updates
Identiy condential and
proprietary inormation
Interpret regulatory
requirements and guidelines
Assess scenarios and
recommend options and
solutions
Address saety issues while
maintaining commercial
viability o products
Manage projects and teams
Manage inspections and audits
Review and approve inspection
and audit communicationsPerorm risk assessment
Respond to risks to address
saety issues while maintaining
commercial viability o products
Negotiate with regulatory
agencies
Review and approve external
communications relative to
regulations
Strategize processes or
marketing products and crating
product claims
Company inormation
management systems
RA Professional Development Framework - Level IV (cont.)
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7/31/2019 PDF Framwork Whitepaper
19/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society
Interfacing
Tasks/Responsibil ities Basic.Knowledge.of Skills.or.Ability.to Institutional.Knowledge.of
Provide training or stakeholders
on current and new regulatory
requirements to ensure
company-wide compliance
Develop, review and approve
corporate-wide communications
to ensure compliance and to
meet business objectives
Advise management andstakeholders on complex
regulatory issues requiring
innovative solutions
Advise management o the
impact o current, newly
nalized or proposed
regulations, guidelines and
standards, and on review
committee recommendations
Advise internal personnel on
requirements and options or
submissions and approvals
Infuence clinical strategy to
ensure integration into the
regulatory and reimbursement
positionCommunicate the companys
regulatory position to business
partners
Manage communication and
negotiation with regulatory
authorities
Strategically plan and lead
meetings with regulatory
advisory committees and
agencies
Utilize expert technical
regulatory skills to infuence
regulators on complex issues
Conduct and present regulatory
due diligence
Lead inspection teamConsult with and advise legal
counsel on regulatory and legal
issues
Participate in the development
o new regulations, guidelines
and/or standards to promote
scientic innovation balanced
with appropriate saety
concerns
Advance the organizations
position by participating and
taking leadership roles in
proessional associations,
industry and trade groups
and appropriate standards
organizations
Regulatory agency and
stakeholder decision makers
Structure o the regulatory
agency(s)
Principles o regulatory
compliance
Routes o external
communications
Dierences in legislativeauthorities
Risk-benet assessment
methodology
Product proles
Developing, pending and recent
legislation, regulations and
guidelines
Process to develop new
legislation and regulation
Standards organizations and
standards development process
Inspection authority and
process
Due diligence process
Reimbursement process and
requirementsCompetitive environment
Current scientic trends
Current issues acing industry
Legal ramework and potential
actions
Eectively communicate with
scientic, technical, business
and public organizations
Analyze regulatory requirements
and their implications
Assess compliance in technical
presentations
Apply risk-benet analysis
techniquesDetermine company regulatory
and legal impact
Present complex inormation
Synthesize applicable data
requirements
Translate regulatory language
into practical business terms
Work eectively across dierent
cultures and languages
Internal inspection procedures
Internal communication routes
Training requirements
RA Professional Development Framework - Level IV (cont.)
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7/31/2019 PDF Framwork Whitepaper
20/21Regulatory Aairs Proessional Development Framework: An Overview 2007 Regulatory Aairs Proessionals Society
ABOUT.RAPS
The Regulatory Aairs Proessionals Society (RAPS) guides and supports individualsrom industry, government,
academia, research and clinical organizationsto bring lie-saving and lie-enhancing products to the global
marketplace quickly and saely.
Founded in 1976 and operating outside the political arena, RAPS provides a neutral orum on emerging science and
global regulatory challenges, oering personal and proessional resources to help RA proessionals continuously
improve and work smarter, aster and in compliance with regulatory models.
RAPS established the regulatory proession worldwide and brings knowledge and progress to it. By identiying scope
o practice, dening core competencies, upholding proessional standards, developing proessional certication,
and providing educational and networking opportunities, RAPS supports proessionals throughout the healthcare
product liecycle.
For more inormation, visit wwwrapsorg.
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7/31/2019 PDF Framwork Whitepaper
21/21
5635.Fishers.Lane
Suite.550
Rockville,.MD.20852
USA.
Tel.+1.301.770.2920
Fax.+1.301.770.2924
wwwrapsorg..
raps@rapsorg.