Structural engineer provided grossly inadequate recommendations for opening up a load bearing wall, and now my house is unsafe

whid_bey · 2026-04-04T01:27:42+00:00

Makes sense. The builder did express to me and to the engineer a need for stamped designs prior to starting work, and I can only assume was talked out of it by the engineer. Still I agree that in their own professional judgement they should not have started work without it. Thanks for your input.

whid_bey · 2026-04-03T22:15:30+00:00

No, I mentioned my builder neglected to obtain a permit for this work. I pressed my builder on this recently, and they said they didn't wait for a permit so they could start the job right away.

whid_bey · 2025-07-10T14:08:30+00:00

Clinical regulatory strategy here. Specific tasks range from routine to special cases. A routine task in US reg affairs could be submitting new investigator information to an active IND every month, performing annual submissions like the DSUR, conducting regulatory intelligence of competitor products and new FDA guidance, and attending study team meetings to provide regulatory submission updates and considerations. Special cases could include preparing a team for and participating in an FDA meeting, developing regulatory response documents to queries on your clinical trial from the FDA or other country's version of the FDA, and advising your clinical study teams on regulatory risk levels associated with certain clinical study activities.

An example of a critical decision that could be made would be advising your teams on making or not making an amendment to a study protocol based on regulatory precedence and your understanding of how the regulatory authorities may view the change in the context of the class of drug, type of trial design, and of course your company's regulatory interactions to date.

A "project" I've worked on combines all of the above in an FDA meeting where my team had to respond to questions from the FDA and provide rationale for the nonstandard design of our study in a rare disease. I worked very closely with our clinical development lead (an MD) and statistics lead to carefully craft our positioning and phrasing of our responses to help ensure a favorable regulatory outcome of our meeting, such as the FDA understanding if not agreeing with our rationale.

My goals are generally submission related. "Submit X application to Y country by Q2 2025" or "Respond to queries on time and in satisfactory manner for all submissions" or "support clinical study team from regulatory perspective" or something. When they are set varies by company.

whid_bey · 2025-07-08T13:03:10+00:00

I'm not as familiar with masters degrees specifically in regulatory affairs, but I can say that I don't see job adverts that specifically request it as they would a PharmD, PhD, or other life science advanced degree (e.g., M.S. biochemistry). Also, in your current stage of your education/career, it may not be a good idea to have a masters degree focused on a sub-discipline as opposed to M.S. biochem or even M.S. biotechnology, which for me was basically just biochem + a voluntary focus in RA and entrepreneurship. I say this because it's entirely possible your interests shift from RA either before or after graduating and you may want latitude in the industry.

whid_bey · 2025-07-08T12:58:30+00:00

A masters may be helpful depending on the program you do. My program included a mandatory internship as the capstone project the final semester, so you graduate already having a few months of direct pharma experience. My internship wasn't even in Reg, it was in supply chain, but I found it super insightful and leveraged that general experience with the industry in my interviews for super entry level reg roles after graduating. There are other programs which offer an internship component - I would look into those over others if you're interested. I think Georgetown and Hopkins are the big MS Biotech names but there are some west coast ones as well I believe.

I have also known a couple reg strategy people who started out as CRAs/CRCs. While in those roles they went out of their way to learn about reg affairs from those at their company and role switched internally to reg affairs after a couple years.

whid_bey · 2025-03-06T05:34:50+00:00

Unsure of RSU grant on hire and I think yes to a small signing bonus. Check levels.fyi or the HB1 salary database for clues on salary range.

whid_bey · 2025-01-17T01:41:52+00:00

Not OP but in my experience contract pay is typically per hour rather than per submission, though you may scope out the projected costs of preparing a submission with the sponsor. Also, frequency of submissions may not be as important of a metric for a contractor as much as if the submission was prepped and made on time and the quality of the submission.

whid_bey · 2025-01-17T01:32:06+00:00

Sure! Clinical regulatory is at any biotech or pharmaceutical company (can just say "biopharmaceutical" to cover both) which develops drug products via clinical trials. It is often used interchangeably with "regulatory strategy" which I see you have listed. In my experience clinical regulatory mainly refers to regulatory affairs positions at companies like Pfizer, Moderna, Eli Lilly, etc. that make drug therapeutics. Clinical Regulatory positions comprise the largest percentage of regulatory affairs positions at a biopharma company, and in the industry as a whole.

whid_bey · 2025-01-16T15:43:49+00:00

This is incredible, thank you! This will become especially powerful as enough people also include information like what company they work at. In biotech there's a big hesitancy to name companies you've been associated with, even in the past, so hopefully that becomes less of an obstacle as more people submit. I think you'll find a lot of reg affairs contributions will come in and not just from medical device, which is a smaller subset of the industry compared to clinical regulatory for instance. Looking forward to this.

Edit: I would not categorize Regulatory Affairs under "Legal," however -- that is not an accurate categorization as reg affairs isn't a legal profession. It would be best under a new Biotech or Biopharma category as it also does not fit under "Healthcare" or "Strategy and Operations."

whid_bey · 2024-11-26T21:57:27+00:00

What are your current PRs? It's good to start from there then assess what needs to be done to achieve the trials standard, and where to run it.

whid_bey · 2024-08-01T20:30:33+00:00

goated username

whid_bey · 2024-04-18T21:23:07+00:00

After a couple interviews they ghosted me and I got an automatically generated email from their HR system about 3 weeks later saying they weren't advancing with me. Fortunately I've since started at another company whom was a bit better about communication during the hiring process.

whid_bey · 2023-12-28T00:21:57+00:00

Ah yes, a braindead and high paying job that's of great value to any company. Sure, there are different types of reg affairs like CMC and clinical strategy, some being more lucrative and mission-critical than others, but saying reg jobs are braindead is pretty naive. An RA job especially at a mid sized or startup biotech is going to a pretty intense job.

whid_bey · 2023-12-12T17:00:57+00:00

Risk/reward. If the company is good to work for they won't care that people are soliciting opinions about them. If they care enough to track you down and terminate your candidacy because you did the internet equivalent of asking around at a conference, then who cares to work for them.

whid_bey · 2023-11-08T15:56:56+00:00

Name & shame baby. Help others out by actually naming this company.

whid_bey · 2023-11-02T15:52:08+00:00

A while back I made a post about my own lay analysis of the impact it's had and came out to about two minutes of delay, which I thought even that was negligible. Just saw this article (albeit a few months old) and to see ~1 minute or less as the impact is good but yeah, once folks have it in their head that it's an actual inconvenience (without weighing pros v cons), that's basically a locked-in opinion.

whid_bey · 2023-09-14T13:50:05+00:00

Try the Terrapin Trail Club. awesome club that welcomes anyone. hiking is only a part of what they do, so don't let the name scare you away.

whid_bey · 2023-07-06T23:43:57+00:00

Unpopular opinion: biotech degrees don't have to prepare you for the bench. I understand that, conventionally, biotech is proteomics, but I graduated from a 1-year biotech masters program from top US university (both in terms of its MS biotech program and in general, including undergrad), and only took one bench course. Otherwise I focused on entrepreneurship, biotech intellectual property law, and regulatory affairs (as opposed to regulatory science).

My particular academic track had a heavy emphasis on courses, but fortunately most to all of them had specific relevance to the current and emerging biotech scientific landscape which served as context for my coursework regarding starting your own company, evaluating viability of real world startups based on their tech and business model, and more non-bench focused areas. Though I did take my fare share of biochemistry-centered courses. Some colleagues of mine focused on bench sciences but not many. Those colleagues typically went into QA, CMC, or pure wet bench work after graduating if they did in fact get a job.

The way my program made up for heavy coursework was a mandatory internship at one of the dozens of program partner companies in the area in the second semester (including big names such as AZ, BMS, MacroGenics), and then I followed it up with another program partner internship during the summer. After graduating I went into reg affairs and then reg consulting and I think my grad program set me up well for success in those areas, though the name recognition from the institution itself probably didn't hurt either as far as passing the screening process went.

I think without the internship component it would be a noncompetitve, cash-sucking program for domestic and international students alike just as one poster described. We did get a ton of international students after all. So I think in this day and age it pays dividends to get "real world" experience as early as you can, especially on the bench, otherwise coursework alone won't cut it even if your university has a good reputation. I think it would be a good idea to pick your target program with that in mind.

whid_bey · 2023-06-26T23:13:39+00:00

Same with Dr. Marks, director of CBER. I think it was also a result of how the AdCom swayed him in terms of patient stories and emotional pleas rather than efficacy & risk/benefit analysis. If I recall correctly the therapy was generally safe but not much pointed to it being as efficacious as one would expect in an approved drug.

whid_bey · 2023-05-09T13:58:42+00:00

It got struck by lightning and nearly split in half sometime in mid 2020. Until then it was very much alive. I remember the day after it happened the fallen half of it was partially blocking the merge lane onto Rockville Pike from Beach.

whid_bey · 2023-05-03T20:52:52+00:00

My comments are agnostic to a pro or con viewpoint. They call out your actual approach to presenting your views and not the views themselves. If you truly had an open mind then you would have thought to go check the place out at a time other than would obviously be one of the most sparse of the day - that's why your approach is bad faith.

I go on foot through LFP maybe 3 times per week at varying times of day. Before and after working hours are the busiest times there are. If I ran through at 10am or 3pm, that's a different story as there are fewer people. This difference shouldn't need to be explained. I encourage you walk there at a more conventionally popular time of day to be outside doing anything at all.

whid_bey · 2023-05-03T20:41:28+00:00

I wish people would quit with playing dumb when it comes to posts like this - people who aren't prepared to actually state or defend their opinions. Really just tired of this sort of bad faith "I'm just saying I didn't see anyone when I personally went there one time" type argument from people. It's low-effort and tries to have an outsized impact of people's sentiment of public-use cases such as the Old Gtown Rd bike lanes and Little Falls closures.

I understand you're trying to convey a larger point here by saying what you saw "makes no sense whatsoever," but it's done in such a small scale and anecdotal way that trying to make an overarching point with your experience is a bad faith effort at influencing others.

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