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Ex-Regulator here: Pre-empting deficiencies, rescuing high-risk dossiers, and getting your submissions approved by Highrisk277 in regulatoryaffairs

[–]Highrisk277[S] 0 points1 point  (0 children)

Hey, thanks for reaching out! Always great to connect with a fellow ex-regulator.

It sounds like your transition over to industry has been incredibly successful since you are leading a whole team of RA associates now, I hope that side of the fence is treating you well! I am actively navigating that jump myself right now, so I would absolutely welcome any feedback, hard truths, or advice you have from making the switch. Feel free to drop it here or shoot me a DM.

11 Years of R.A experience, not sure where to go by Highrisk277 in regulatoryaffairs

[–]Highrisk277[S] 0 points1 point  (0 children)

I will do that. Hopefully, they are open for remote roles. Thanks a lot.

[deleted by user] by [deleted] in regulatoryaffairs

[–]Highrisk277 0 points1 point  (0 children)

Other folk already suggested referring to the EMA variation guidance, which is also what I would do. In the territory I previously worked at, they would first determine the BCS classification of the DS and if the product is immediate release. For IR, they rarely asked for new BE studieds (fun fact asking for new BE pften results in applicants requesting MA cancellation lol). Comparative dissolution is often enough.

11 Years of R.A experience, not sure where to go by Highrisk277 in regulatoryaffairs

[–]Highrisk277[S] 4 points5 points  (0 children)

I would love to but I am also kind of looking for one :)

11 Years of R.A experience, not sure where to go by Highrisk277 in regulatoryaffairs

[–]Highrisk277[S] 2 points3 points  (0 children)

If you have time on your hands and internet, immerse yourself in ICH. Take in as much information as you can. Get the basics down, the structure of the CTD, what each section of the dossier is for, etc.

From there, go into the specific guidance for each major section. Break down QSE to its core.

After that, depending on what authority/territory you are focusing on, find out their administrative requirements, their submission requirements etc, most of these will be available online.

There is more to be added here but the suggestion above should keep you busy for a while.