I currently work on IRB submissions, but looking to make a switch into FDA-related regulatory affairs. Just cold applying for Regulatory Affairs Specialist roles isn’t cutting it, as I assume they have applicants with more FDA-facing experience. Does anyone have advice for me? I’d to hear stories on how others were able to break into this role or similar ones.

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Posting as :
works at
You are currently posting as works at

Have seen people do IRB -> CRO (IHCRA) -> Reg Affairs (same CRO)

Always easier to transfer within a company than, although quite possible and lucky to make the move you’re talking about as well.

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Would you consider working at an agency that works to create content for pharma clients? Content such as websites, brochures, emails, etc. There is a role called “Submission Specialist” and companies like Havas Health and You, Tag WorldWide, Omnicom, etc. are examples of the agencies that have this role.

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