Hi Alaa,
You don't specify drugs/biologics or devices. So, I will presume drugs/biologics in my response.
I would start with the basics:
- Regulatory Strategy: Typically, the staff in this group are the Global (and Regional) Regulatory Leads for the program teams and principally support Clinical and Nonclinical activities. The staff in this group are also usually the main point of contact with regulatory health authorities. This is usually the largest group within Regulatory.
- Regulatory CMC: The staff in this group work closely with the manufacturing, analytical, and Quality Assurance groups; they also serve as a bridge between the CMC and the Clinical arms of the organization. In a small organization at early stages, this may be outsourced. About Phase 2, I would hire an internal Reg CMC person.
- Regulatory Operations: The staff in this group support submission preparation and management, publishing (or coordinating with external publishing CROs, archiving, etc. In a small organization, this may be 1 person.
Within a year of commercialization, you would also need a
Promotion / Advertising / Labeling (PAL) group in Regulatory to work with Marketing/Commercial.
Some Regulatory functions also include
Medical Writing &/or
Pharmacovigilance, if the organization chooses.
I'm sure others will share their perspectives, as well, so you will get a good cross-section of thoughts.
Good luck!
Mark
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Mark De Rosch, PhD, FRAPS
Epizyme, Inc.
Cambridge, MA
United States
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Original Message:
Sent: 07-Mar-2021 01:24
From: Alaa El Kazak
Subject: RA (drugs) functional teams
Dear Regex,
What are the main functional teams that should exist in an RA department? noting that this RA department centrally serves multiple regions at the same time.
Your suggestions and real life examples will help a lot.
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Alaa El Kazak Msc., RAC
Jeddah
Saudi Arabia
https://www.linkedin.com/in/alaaelkazak/
http://bcert.me/snztdjygk
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