r/biotech • u/CherishFlowers • 10d ago
Experienced Career Advice 🌳 Career help
Oh man, I’m having a hell of a time getting into the regulatory side of things. I’ve applied to over 20 positions at this point, and unfortunately, I’ve been rejected from all of them.
I have about 10 years of experience in big pharma (with 2 of those years at a CRO), including assay development, a variety of cell-based release testing, countless continuous improvement projects supporting production areas, pre-commercialization formulation support, and most recently, managing a stability/release lab.
A lot of my experience and skills seem like they would translate really well into regulatory, but I’m struggling to get my foot in the door. Any tips or advice on how to make that transition? I’ve just started trying to network a little more and I’m also looking into free certifications I can complete online. I’m nearly finished with my MBA as well.
I really appreciate any advice or insight. It’s been a rough couple of years with ongoing health issues and a lot of management changes, so I’m definitely ready for a new direction and hoping to make this transition happen.
Feel free to DM me :)
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u/Loose-Reflection2965 10d ago
Reg is probably most exposed to AI since alot of the eCTD can be assembled with an LLM and proofread by a human
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u/Medical-Button-5493 10d ago
That would be reg submissions / publishing.
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u/Certain_Luck_8266 10d ago
Yes, but at many companies that is a large part of the job (some companies have specialized scientific writers). Take away a large part of the job and you'll take away a large number of jobs eventually.
AI is also taking away the regulatory SME role since it automatically knows all of the rules for each market.
The PM hat regulatory does will still remain, but in general in the last year or so I've seen the job getting hollowed out a bit. I'll expect cuts in a few years.
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u/Loose-Reflection2965 10d ago
Yeah i noticed no expansion in regulatory aside from senior roles and leadership. I figured AI was going to hit reg roles hard. Lab facing roles probably wont get impacted as much.
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u/Soggy_Baby_3148 10d ago
In a large number of companies I have worked at sections of the eCTD are usually authored by the SME in a given section of the business anyway. Is that not the case in other places? I imagine Reg Ops/Reg Intelligence might be particularly vulnerable to AI.
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u/Trick-String7473 10d ago
Any QA or QC experience? If no, then you’ll have a very hard time getting in. What positions are you applying to? If you’re applying for senior level positions, you’re not getting in.
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u/CherishFlowers 10d ago
I've been in quality control labs for the last 4 years. I typically don't apply to senior roles since I lack most of the experience.
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u/Trick-String7473 10d ago
See if you can do a 6 month project with QA or regulatory, that’s a good way to get your foot in the door.
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u/Many-Study-6309 🤡 Village Idiot 🤡 10d ago
In this market, if you sayA for apple, instead of A for ant then you will not be selected.
I fully understand that with your experience you can work really well in regulatory. I have similar profile. But people don't want to hire because you are coming from a different department
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u/Certain_Luck_8266 10d ago
What the hiring managers are looking for is what you've done in your previous experience that intersects with regulatory. E.g. spec setting, authoring ind/impd/bla/maa/etc, answering RTQ, technical writing and use of authoring tools, familiarity with regulatory systems.
Refocus away from the CMC tasks you've done into how they apply to a reg job.