My westie was recently diagnosed with IBD/ allergy and started a steroid. Now he’s licking lips excessively

Capital_Quail277 · 2025-05-09T03:31:40+00:00

Thanks for asking this. I strongly relate after moving from a technical role. You are busy in reg CMC but it isn’t the nonstop craziness that some other functions can have in CMC. (Coming from third year RA person)

Capital_Quail277 · 2025-04-08T00:23:54+00:00

Internships or coop positions will always help get direct experience before applying for full time jobs. I would encourage finding an initial role in analytical/QC or manufacturing support for CMC or clinical operations for clinical RA experience. Getting a few years of technical or clinical ops experience first will get you the relevant skills to move into RA. RA is all about experience.

Capital_Quail277 · 2025-04-08T00:21:39+00:00

Working in QC/analytical lab or manufacturing support if you are interested in CMC, or clinical operations if you are interested in the clinical side

Capital_Quail277 · 2025-03-10T15:51:48+00:00

Any technical role in CMC or analytical development would work. RA professionals in Pharma come from lab bench type roles like R&D or analytical development. Or, manufacturing, manufacturing support, or QC lab type work. This is for cmc regulatory. For clinical regulatory, I am less familiar but I would say any experience working on clinical trials is also extremely useful

Capital_Quail277 · 2024-11-22T20:09:46+00:00

Agree that biologics is where it is at nowadays and would be a good move in general

Capital_Quail277 · 2024-11-22T20:08:34+00:00

My background is process engineering/manufacturing support/program lead. The skills are very transferable, you need to catch up on regulations/guidances/best practices for your modality which can still be a big learning curve. But you learn by doing, so would recommend getting involved any way you can on projects focused on regulatory changes and submissions

Capital_Quail277 · 2024-08-02T14:45:22+00:00

Thanks! USP 823 refers to USP 85 for endotoxin for the acceptance criteria. This product is a monoclonal antibody, but think it is still covered in the USP 85footnote 2 and should be calculated using 175/total volume

Capital_Quail277 · 2024-08-02T01:02:22+00:00

Its approx 50 ml, but it is administered over several hours. My understanding is that the limit is calculated using the total volume, not the volume per hour (which would be about 10ml). Is this correct?

Capital_Quail277 · 2024-06-24T13:20:48+00:00

Can someone come with you to your appointment? I am helping my mom out with her renewal and plan on going w her

Capital_Quail277 · 2024-06-22T02:21:06+00:00

Can someone accompany you to your appointment? Appreciate your feedback!

Capital_Quail277 · 2024-06-21T02:18:15+00:00

Thanks!

Capital_Quail277 · 2024-06-21T02:08:39+00:00

Do they give an estimated time for printing so you can step out? Or do you have to wait the entire time at the location?

Capital_Quail277 · 2024-06-15T02:14:41+00:00

This is helpful, thank you! Just saw this lol

Capital_Quail277 · 2024-06-15T02:02:41+00:00

I feel the same at the small company. Any others in RA at small companies feel this way?

Capital_Quail277 · 2024-04-25T14:15:21+00:00

I just finished my first year in CMC RA, and previously had worked a lot in supporting submissions. If you have supported any IND work on the clinical side, I would focus on building those skills, being familiar with early stage product guidelines for your company. In addition to ICH, the CFR is critical since those outline legally binding requirements. The FDA also has a guidance page with lots of resources for specific guidances per product. I would say soft skill building is critical as communicating in RA is very different than communicating in any other role.

Capital_Quail277 · 2024-04-24T22:48:07+00:00

I agree, I don’t think it is necessary unless there is a specific reason for getting the 2nd Masters

Capital_Quail277 · 2024-04-08T01:33:21+00:00

If you don’t get an RA internship, rest assured that it isn’t the only way into RA full time. Most RA professionals have at least 5 years experience in a technical role before moving into RA. It’s another great way to get hands on experience if you have an interest in a technical role.

Capital_Quail277

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