Any advice for fed employee looking to switch from FDA to private industry? I have a PharmD, did residency in managed care, then worked for 3 years at PBM before joining HHS in Medicare Part D formulary for 2 years. I switched to FDA-OND 9 years ago and have worked as regulatory project manager for drug applications/reviews (IND/NDA/BLA) and as a clinical analyst in post-market surveillance (PMR/PMC). Looking at regulatory affairs roles but open to other roles that might be good match.

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You have incredible skills and you will be an asset to the pharmaceutical industry. If you are laser focused on RA role (I am assuming you are open to pharmaceutical companies) do a detailed review of couple of job advertisements for regulatory affairs roles and do a gap analysis to see where you gaps are and see whether your current role has enough transferable skills to bridge these gaps. If the gaps are things you can learn in the job or via training - I would recommend tailoring your CV specifically for these roles and ensuring your cover letter “tells the story of your motivation for the switch” and how you plan to bridge any gaps assuming these are just minor. Having someone with your background is a huge plus for any pharmaceutical company because your insights would be valuable for submission. I would start there and send your CV out and see what you get. Also check on Linkedin as there are people who have made this switch perhaps reach out to them to network? Your skills are impressive and any RA group would be happy to have you in their team. Good luck!!

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Solid Gov experience is always rewarded in Pharma

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I am sure any organization will be happy to have your expertise. What kind of levels are you looking at?

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I would think Director role would be easier for you to first find your footing in the industry, and then you can always pivot to more senior roles. The thing is you have a unique niche and if I may suggest instead of big pharma, think of also joining consulting as an advisor role. It all depends on what you are looking for really, work life balance vs $$$ vs work preference as in kind of projects. I made a similar transition many years ago from CMS to big pharma and let me know if you have any questions

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Besides regulatory affairs, quality assurance in audits/inspection readiness would also be a good fit. I have worked with previous FDA in this role

Alternatively: healthtech.

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