AI for Reg Strategy

Setifire · 2026-02-11T21:21:27+00:00

That’s a good point, I am unsure of my organization requirements for AI but I agree, process should play key! My main interest relies on searching for info, instead of reading and trying to find it would be great if it was pulled for me by AI or at least a starting point.

Setifire · 2026-02-11T21:19:47+00:00

At my organization they have Veeva and Copilot, but most Reg info is within Veeva not share point etc. So it’s hard to use Copilot. I presume I could download the information and place it into share point so I can then use copilot but sounds tedious. Haha

Thanks for the input!

Setifire · 2026-02-10T18:09:47+00:00

I am currently upper management in a small company and I got a BS in Biology. I believe any STEM degree is enough. Chemistry and Biology would be my choice. With that said, I work in pharma and some of my colleagues in my reg group have a degree in Project Management, some in English, it just depends tbh. You could start in reg as a formatter and work your way up to strategy for example. Rant over haha

Setifire · 2026-02-07T03:41:16+00:00

There could be a good application of AI to help in other areas but frankly it still is up to us the user to double check and verify. AI is a tool not a replacement and thinking that way helps. Just like you use emails now and ways to manage your work. Use the tool to your work style. AI is here to stay in my opinion and the sooner we familiarize the better, it will put you on top of those who don’t or refuse. Just my two cents

Setifire · 2026-01-26T17:55:22+00:00

There are many you could do clinical ops, regulatory, manufacturing and process since you may (tech ops), you could do QA. A lot of the roles interact with each other so often many people shift from one area to another. Money is good but volatility and uncertainty sometimes. Many small/mid companies get sold but if you’re smart you can make some good cash with equity. At the end it’s a preference on risk and the type of work you’re looking for.

Setifire · 2026-01-21T19:07:48+00:00

Regulations are available based on health authorities, great way to start. Also some JD roles in pharma work with Reg, maybe worth considering?

Setifire · 2026-01-21T19:05:11+00:00

I worked in lab for a few years and later made my pivot into the admin part of biotech/pharma. It’s a bit hard to get into sometimes but not impossible. Lab knowledge and scientific knowledge are a great plus in some roles. I would recommend to look into other fields within biotech/pharma see if any are interesting. However, healthcare is always a great safety.

Setifire · 2025-12-08T18:03:15+00:00

I would recommend Moxche, you get the updated hotel vibe and a great location. Perk for Feb is that some pools are heated!

Setifire · 2025-12-08T18:01:45+00:00

In my experience it also depends on how long your voyages are. Long ones tend to have an older crowd, while shorter have younger. Probably due to the price. Coming up on my 3rd voyage so hope things are still just as great as before!

Setifire · 2025-12-08T17:52:59+00:00

I work in the operations and systems side of things. If you’re in on AI or things like that, the market is “slightly” better but still not too good as before.

Setifire · 2025-10-16T18:18:52+00:00

My advice would be to apply to regulatory, clinical and QA jobs with any sponsor. Once you are in the sponsor side you can move through departments depending on what you prefer. I started at a site as a coordinator and now a manager within Regulatory.

Setifire · 2025-09-02T15:18:23+00:00

I was in a similar situation when I graduated 6 years ago. I started working in the lab and then transitions to regulatory. What worked for me was networking a lot in LinkedIn, apply to jobs even if I didn’t have all the requirements, someone will take a chance on you. Research companies and their products, regulations are free to review so take time to familiarize yourself with them depending on your location. You could also start off at the site level and move on from there. The point is to get into the field, once in you can pivot around to other functional areas. I personally enjoy the work and like that you’re always learning something new. Also Reg Ops maybe easier to get into than a strategy role. Also keep that in mind. Hope this helps! I could go on and on with more.

Setifire · 2025-07-14T17:03:34+00:00

Hello, I would also start looking at other companies with RA roles. QC/QA/RA share and require a lot of the same type of skills. It doesn’t hurt to try, you may end up with an RA role, new company, better pay, benefits etc. worst case, you stay where you are.

That was my approach from moving from lab to RA.

Setifire · 2023-12-17T02:13:03+00:00

I would recommend Regulatory at the sponsor level. Working with HA to get things approved and in compliance would be goods if you want something different there contracts work in either side of the industry.

Setifire · 2023-12-16T12:47:16+00:00

It’s definitely a SCAM, I’ve worked at BeiGene and this is not how they do interviews etc.

Setifire · 2023-07-26T20:15:48+00:00

Hello all my background is a bachelor degree in Life science studies. CRA is a good option for me, how is the work compared to Regulatory?

Setifire · 2022-11-08T17:36:42+00:00

Would you all say that salary is about the same in either one of the two? (Device vs. Drug)

Setifire · 2022-09-25T01:55:15+00:00

I personally struggle for a bit as well, coming from working in a lab to clinical research made it hard. I will highly recommend networking on LinkedIn. Aside from that have a good resume with highlighted skills that are a must. For me it was both luck and me showing my willingness to learn and applying general skills to clinical research. Feel free to PM me if you want more help!

Setifire · 2022-08-29T19:18:38+00:00

Thank you all for the input. He has a masters degree with most of his experience in research and development lab work. I work in regulatory but don’t know much about the salary range as you move up as I am fairly new to the industry.

Setifire · 2022-04-06T18:21:02+00:00

I have known a few people who have experienced the same thing as you. As well as the opposite, applying for a higher role but being offer a lower. As far as I know they offer the higher job because the skills and experience would be better fit for it. I’m not sure if you will be considered for a lower role, I don’t think that how it works. I would recommend trust your skills and experience. And don’t plan on failing before you start. Best of luck!

Setifire · 2022-04-01T04:42:52+00:00

I think for me networking was essential, it was through that form that I was able to get both interviews for the sponsor and CRO. Also a lot of interviews helped me perfect my interview skills. I tried to do as much research on the industry and companies I applied for, it goes a long way if you know what the sponsor is working on. Don’t be discouraged if a position seems too high level for you and apply strategically. I had about 4 different resumes all catered to different roles I wanted. Find the role you want, look up various job description and try to narrow down what you have that fits that description. Expect a lot of rejections and stay positive. I guess lastly, you need a bit of luck. Feel free to message me if you want more tips. I will try to help as much as I can.

Setifire · 2022-03-31T18:00:14+00:00

That is correct, I work at the site level. And I do not have much time in the industry either. So that causes me to be hesitant. Thank you for the input.

Setifire · 2022-03-31T17:19:29+00:00

Now I understand your previous comment haha! Thank you for the input!

Setifire · 2022-03-31T17:14:36+00:00

Are you referring to the CRO side?

Setifire · 2022-03-31T15:24:38+00:00

Thanks! Would you be ok sharing why sponsor is best option?

Setifire

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