Chapter 1: A General Framework for Regulatory Intelligence in Medical Product Research and Development
6 Regulatory Affairs Professionals Society
organizations such as RAPS,2 DIA,3 and the Organisation
for Professionals in Regulatory Affairs (TOPRA)4 also offer
sessions and workshops specifically on RI skills.
RI Processes
Focusing on processes has benefits and drawbacks. Processes
can help ensure consistency, quality control, and make it eas‑
ier to train and onboard new colleagues. However, too much
focus on process can slow down innovation, make it hard to
adapt to regulatory changes, and lower morale if employees
feel restricted by strict rules. With this in mind, the processes
described here are meant to guide, not dictate, how you
approach RI.
Moving from left to right across the four RI components
of the framework, raw data and information are collected
from sources and transformed into insights that drive intelli‑
gent actions within the organization (Figure 1-5). Although
each organization may organize its processes around its
unique needs, there are some core RI processes that we’ll
unpack here.
Observation Processes. Defining the regions, topics, and
therapeutic areas of interest to your organization is crucial
for tailoring research and development efforts to specific
needs and opportunities. The selection of regions, topics, and
therapeutic areas is driven by numerous factors specific to
each organization, including the types of products, stage of
development, commercialization plans, leadership interests,
and other factors. The key is that each organization needs
to identify where and what its RI program should focus on.
These areas of focus should be periodically reevaluated to
ensure the RI program consistently meets your current busi‑
ness needs.
Figure 1-3. RI Roles in a Small Organization
Observe
• Head of Regulatory
Affairs and Quality
Assurance
• Head of Regulatory
Affairs and Quality
Assurance
• Subject matter
experts (SMEs) as
needed
• Head of Regulatory
Affairs and Quality
Assurance
• SMEs as needed
• Head of Regulatory
Affairs and Quality
Assurance
• SMEs as needed
Communicate Evaluate Act
Source: Chris Whalley
Figure 1-4. RI Roles in a Large Organization
Observe
• Intelligence analyst
• Regulatory affairs
specialist (including
Reg CMC)
• Quality &compli-
ance analyst
• RegOps or submis-
sion specialist
• Safety analyst
• Data analyst
• Subject matter
experts (SMEs) as
needed
• Intelligence analyst/
manager
• Regulatory affairs
specialist (including
Reg CMC)
• Quality &com-
pliance analyst/
manager
• Safety analyst/
manager
• RegOps or submis-
sion specialist
• SMEs as needed
• Intelligence
manager
• Regulatory affairs
manager
• Regional regula-
tory/labeling lead
• Policy analyst
• GxP quality &com-
pliance manager
• Safety &pharma-
covigilance manager
• RegOps or submis-
sion manager
• SMEs as needed
• Global regulatory
strategist/lead
• Global labeling lead
• Policy advisor
• GxP quality &com-
pliance manager
• Safety &pharma-
covigilance lead
• Audit &inspection
manager
• RegOps or submis-
sion lead
• SMEs as needed
Communicate Evaluate Act
Source: Chris Whalley
6 Regulatory Affairs Professionals Society
organizations such as RAPS,2 DIA,3 and the Organisation
for Professionals in Regulatory Affairs (TOPRA)4 also offer
sessions and workshops specifically on RI skills.
RI Processes
Focusing on processes has benefits and drawbacks. Processes
can help ensure consistency, quality control, and make it eas‑
ier to train and onboard new colleagues. However, too much
focus on process can slow down innovation, make it hard to
adapt to regulatory changes, and lower morale if employees
feel restricted by strict rules. With this in mind, the processes
described here are meant to guide, not dictate, how you
approach RI.
Moving from left to right across the four RI components
of the framework, raw data and information are collected
from sources and transformed into insights that drive intelli‑
gent actions within the organization (Figure 1-5). Although
each organization may organize its processes around its
unique needs, there are some core RI processes that we’ll
unpack here.
Observation Processes. Defining the regions, topics, and
therapeutic areas of interest to your organization is crucial
for tailoring research and development efforts to specific
needs and opportunities. The selection of regions, topics, and
therapeutic areas is driven by numerous factors specific to
each organization, including the types of products, stage of
development, commercialization plans, leadership interests,
and other factors. The key is that each organization needs
to identify where and what its RI program should focus on.
These areas of focus should be periodically reevaluated to
ensure the RI program consistently meets your current busi‑
ness needs.
Figure 1-3. RI Roles in a Small Organization
Observe
• Head of Regulatory
Affairs and Quality
Assurance
• Head of Regulatory
Affairs and Quality
Assurance
• Subject matter
experts (SMEs) as
needed
• Head of Regulatory
Affairs and Quality
Assurance
• SMEs as needed
• Head of Regulatory
Affairs and Quality
Assurance
• SMEs as needed
Communicate Evaluate Act
Source: Chris Whalley
Figure 1-4. RI Roles in a Large Organization
Observe
• Intelligence analyst
• Regulatory affairs
specialist (including
Reg CMC)
• Quality &compli-
ance analyst
• RegOps or submis-
sion specialist
• Safety analyst
• Data analyst
• Subject matter
experts (SMEs) as
needed
• Intelligence analyst/
manager
• Regulatory affairs
specialist (including
Reg CMC)
• Quality &com-
pliance analyst/
manager
• Safety analyst/
manager
• RegOps or submis-
sion specialist
• SMEs as needed
• Intelligence
manager
• Regulatory affairs
manager
• Regional regula-
tory/labeling lead
• Policy analyst
• GxP quality &com-
pliance manager
• Safety &pharma-
covigilance manager
• RegOps or submis-
sion manager
• SMEs as needed
• Global regulatory
strategist/lead
• Global labeling lead
• Policy advisor
• GxP quality &com-
pliance manager
• Safety &pharma-
covigilance lead
• Audit &inspection
manager
• RegOps or submis-
sion lead
• SMEs as needed
Communicate Evaluate Act
Source: Chris Whalley