r/regulatoryaffairs

regenold GmbH - a regulatory consultancy company in the life sciences with over 30 years of activities and counting more than 100 experts - just launched a competition for AI agent builders in regulatory affairs.

If you are a conversational AI agent builder or practitioner working in the regulatory space, participation in this competition provides you with a meaningful benchmark about the accuracy and reliability of your system on a common use case: the EU AI Act.

Participation is free and open to anyone.

The steps are:

1. Get in touch: Send your endpoint details and participant information to our technical contact. We confirm onboarding and reserve your benchmark slot.

2. We run the evaluation: We send conversation histories to your API and collect the JSON responses. Latency and multi-turn behaviour are measured automatically.

3. You receive your report: Your individual report shows performance across several dimensions, alongside reference benchmarks from popular off-the-shelf methods.

For more info: https://regenold.com/landing/ai/eu-ai-act-competition and info@regenold.com

When a product-related event happens — complaint trend, service issue, labeling concern, software/parameter change, CAPA screening, or risk-file review — where do the related records actually surface?

Do CAPA history, complaint evidence, risk controls, prior similar decisions, and external signals appear in the same review workflow?

Or does someone usually have to reconstruct the evidence manually across QMS, PMS, risk files, emails, spreadsheets, and public databases?

I’m trying to understand whether the real gap is “lack of evidence” or “evidence appears too late at the decision point.”

Hello! I am a 28-year-old female who moved to Germany 9 months ago, thinking I would build the career I always dreamed of. Unfortunately, nothing has worked out so far; I have sent hundreds of applications and received no replies. Because of this, I stopped relying only on English and focused on learning German to reach the B2 level. I hold a bachelor's degree in biomedical sciences from Syria and an honors master's degree in medical biotechnology from Moscow, Russia. How would you advise me to get into Regulatory Affairs in Germany? I am highly interested and don't care how hard it is—I just want to know what the right steps are. Thank you all in advance for any piece of information!

Please tell me where can I get eu label and packaging guidelines from Europe ?

Hi Everyone,

Wanted to make a post, having just made a comment on post in this thread.

I started a Interview/Podcast series called Regulatory Voices, its a 45m - 1hr show where I interview Regulatory professionals in Pharma and Biotech, from Snr Manager to VP/SVP/CRO.

It is a weekly show that airs on LinkedIn, with it also going up on YouTube, Spotify and Apple Podcasts.

The day after an episode airs, a written report goes up on LinkedIn which covers the questions and answers, making it easier for those who haven't got time to watch to still engage.

The reason I started it was the frustration in finding genuine and insightful content which is focused in Regulatory Affairs that isn't just how to break in, interview tips or how to format your resume.

So far we have uploaded 6 episodes and we have had:

1. EX-FDA who moved into Non-Profit Regulatory work
2. PharmD who did a fellowship, worked in small & big companies and went through an acquisition all in their first 6 years
3. Chief Regulatory & Quality Officer who started in EU & UK, then relocating to US
4. SVP Regulatory & Quality who started in Australia, then across APAC, now in the US
5. Chief Regulatory & Quality who is working on cutting edge Ophthalmology work which is utilising Cell Therapy in combination with a small molecule
6. SVP of Regulatory, ex Physician from China who moved to the US then got into Medical Device Regulatory, then ending up in Pharma & Biotech

Some of the topics we have discussed so far are:

• Transitioning from academia/science into regulatory
• Career growth through uncomfortable transitions
• Evolution of regulatory careers over decades
• Building confidence early in career
• The importance of mentorship
• Learning through FDA interactions
• Small biotech vs large pharma environments
• Regulatory as interpretation, not just rules
• Regulatory as an art, not just a science
• Judgment vs pure technical knowledge
• Creativity within regulatory strategy
• Regulatory as an integrator across teams
• Transition from technical expert to leader
• Executive presence
• Communication and stakeholder management
• Regulatory and Quality leadership
• Soft skills vs technical skills
• Investor and executive communication
• Public service mindset and life inside FDA
• Human dynamics in agency interactions
• Drug development data sharing
• Rare disease collaboration and non profit repositories
• Regulatory as interpretation, not just rules
• Regulatory as an art, not just a science

Full disclosure on my side, I am a Recruiter who has focused solely in Regulatory Affairs for the past 6 years, I wouldn't have got to where I am today without the support, passion and patience from those of you in this industry.

I won't ever shill my service in the interviews or here, this content is for you all and I hope that comes across in the interviews.

Lastly, if there are any topics you would like to see please let me know, I have many people who want to take part. If you would be interested in joining an episode feel free to reach out as well.

The links to everything are below:

My Personal LinkedIn profile

Regulatory Voices LinkedIn page

Spotify

Apple Podcasts

YouTube Channel

So today I took an elderly family friend’s payment up to OrthoVirginia because I was already out running errands. I had:
the bill
the envelope it came in
the account info
and the actual $5 bill payment
Simple, right?
Nope.

Front desk tells me they “can’t take the payment” because I’m “not on her HIPAA.”
I just stood there blinking for a second because… what?? Since when does HIPAA stop people from PAYING a bill?

I wasn’t asking:
what procedure she had
what medication she’s on
what her diagnosis is
how much the total balance is
nothing medical whatsoever
I literally just wanted to hand them five dollars and leave.

What’s wild is I’m actually HIPAA trained myself, and I’ve NEVER heard of HIPAA meaning:
“Sorry, we cannot physically accept money from another human being.”

At this point I feel like some offices use HIPAA the same way stores use “the system is down.” Just say it’s office policy. Just say your software won’t allow it. Just say the manager told you not to. But don’t act like federal law prevents grandma’s neighbor from helping pay her copay.

Meanwhile if Mrs. Shirley had sent her grandson, church usher, mailman, or Bingo partner with the same envelope… are y’all really turning away FIVE WHOLE DOLLARS every single time?

Healthcare already stressful enough without folks weaponizing words they barely understand.
Anybody else run into offices blaming HIPAA for stuff that clearly ain’t HIPAA? I even said just mail her the receipt. #orthovirginia

The guidelines say “immediate use” which is obviously intentionally vague. What’s the industry standard for how long you have to use a DS in DP after it passes retest? 30 days?

I recently had an interview experience that left a bit of a bad taste in my mouth, and I’m wondering how common this is.

I interviewed with a major life sciences company in the RA dept. that posted a clear salary range for the role and required applicants to enter a desired base salary in the application. I listed a number roughly in the middle of the posted range, about $35k below the top end.

During the interview, the recruiter asked whether there was “wiggle room” on my number, which already felt a little odd given where it fell within their stated budget. They then explained that the budget for the role had apparently changed quite a bit and that they wanted to go back to HR with a “more reasonable” number as the lower end of the posted range is closer to what they were looking for.

I was honestly a little perplexed. Presumably the salary range was approved before the role was posted, so it felt strange to suddenly be negotiating against an entirely different range after the fact. I did move forward to another interview stage, and I wasn’t looking to be argumentative in the moment, but the whole interaction felt a little…icky? Almost like the goal was to get candidates in the door with one range and recalibrate expectations later.

Another thing that stood out to me was how aggressively they were trying to move the process along. There seemed to be a lot of urgency around hiring quickly, and I was immediately asked back for a second round interview which happened the very next day. I wasn’t sure whether the speed was genuine urgency or part of trying to get candidates emotionally invested and moving fast before they had time to really step back and evaluate things.

I had the complete opposite experience with another company interviewing for a nearly identical role. During the first-round conversation, the recruiter asked about my salary expectations and I gave essentially the same number and they actually responded with something along the lines of, “Got it, so more like XYZ,” and adjusted it upward by about $10k.

Again, relatively new to this so just trying to understand if that first company is a red flag or if that is common before my third round interview. Thanks!!

I recently joined RA in January 2026, and I have been struggling so much till the point where I keep telling myself that this is not the job for me. But in all honestly, I want to try and give my best. Those that have been working for RA for years, any advice for a new hire like myself?

Hi everyone

I've been at a role for 6 months. I was previously QA release and offered a QA/RA role at a MNC affiliate where we import generics, medical devices and cosmetics, and oversee some local manufacturing sites.

I was so excited to enter the RA space but I'm realising I am hating my job. There's only 3 of us and we share the RA/QA/PV work, I'm also deputy QPPV.

I'm worried about staying at this company as my role is far too broad, the work is too much, and I barely have time to do RA. I plan to one day move to EU and get into RA but I'm not sure if my broad experience is going to hurt me, or if I should just find an RA only role. I'm based in South Africa.

My current tasks are split over mainly QA, project management, and some RA. Tasks that I mainly do are:

- batch releases (solely my responsibility)

- lead auditor

- product complaints & AE reporting (I also arrange couriers for replacements)

- training of learnership staff

- ordering reference standards and coordinating lab readiness for post importation testing

- QMS management

- reviewing third party approvals

- obtaining quotes and approving them for labs

- QA activities (vendor management, APQR, temp excursion monitoring, deviation approval, change control)

- coordination of site transfers and new launches

I've done some RA:

- preregistration queries

- due diligence on new product dossiers

- minor variations

- currently busy with site transfer variations

- compilation of new dossier

- renewal submission

It's just currently I'm only doing 1 RA submission a month.. and I'm worried since QA is all under me that I'll constantly be stuck in QA. I'm only deputy QPPV but I'm involved in audits.

Really feeling like this is too much work for 3 people (including the lead pharmacist).

My qualifications are registered pharmacist and I'm currently obtaining my master's in pharmaceutical Affairs. I've got 2.5 years industry experience and 1 yr hospital, since graduation in 2022.

Hi, im a student about to go into university in a year and get my degree and im doing research about regulatory affairs and wanted to ask if the job is even semi-enjoyable? Or maybe its just neutral and boring but it could be worse?

I have a full ride scholarship for university and plan to move to a new country for it, i have an exceptionally high GPA, Been winning awards since i was 10 etc etc but even though im smart on paper i am absolutely horrible at math specifically, As in i'll have an A+ in every other class but a C in math and frankly im terrified of jobs that require math since alot of them do so do you use advanced math on the daily?

I also have someone funding all my expenses for atleast seven years but was unsure how long the schooling was? When i searched it up it said like 5 years but ive heard certain careers have short schooling times on paper and then when you try to hit the job market you find out you need 14 other degrees to compete with other people.

If you have any more detailed answers on this lmk:) Really thinking about pursuing this career.

Could you suggest some unique and innovative review article topics for an M.Pharm programme in Regulatory Affairs, particularly within the Indian pharmaceutical and healthcare regulatory framework?

Tell unique topic for mpharm regulatory affairs review article

Suggest unique topic for mpharm regulatory affairs review article ?

Hi all. I’m currently in the process of developing a medical device in Canada and I’m trying to put together a roadmap of sorts so I can understand the process of bringing a device to market.

I’m brand new to the industry and don’t really know what I don’t know. I would love to pick the brain of someone who’s done it all before.

I appreciate any advice on educational resources, industry organizations to join, direct contacts to reach out to, conferences to attend, etc. or just any advice you may have.

Edit: the device is a class II drape made mostly of transparent plastic.

Question for QA and regulatory folks:

When you look at FDA 483s or audit findings, how many are actually caused by people not knowing the procedure… versus people failing to execute correctly under operational constraints?

Because it feels like most organizations already have:

• SOPs
• Training
• LMS systems
• Documentation
• QA oversight

Yet deviations still happen during real-time execution.

I keep thinking about whether compliance tools should function less like document repositories and more like navigation systems:
Instead of showing entire manuals, the system continuously guides the user to the next correct action based on context.

Has anyone seen systems moving in this direction?
Or is the industry still mostly focused on static documentation?

Hi everyone,

I’m curious to know whether anyone in Regulatory Affairs has used programming or low-code tools to build custom solutions for their daily work.

For example:

. Dashboards to track submissions, approvals, and renewals

. Process management tools

. Automated document generation

. Deadline and milestone trackers

. Data extraction from PDFs or spreadsheets

. Integrations with systems like SharePoint, Veeva, or eTMF platforms

I’ve been exploring ways to automate repetitive tasks and create better visibility into regulatory activities, and I’d love to hear what others have built.

Hi everyone,

I’m looking for advice on transitioning into regulatory affairs and would really appreciate guidance from people who’ve made similar moves.

My background:

• PhD in Biomedical Engineering
• Worked for ~2 years as a Field Application Specialist
• Currently a postdoc at a U.S. national lab, working on a critical federally funded project

My current appointment is ending soon, and I want to move out of research and transition into regulatory affairs (likely medtech / biotech / diagnostics).

I don’t have direct industry RA experience, so I’m trying to figure out the smartest way to bridge the gap.

Specifically, I’d love advice on:

1. What should I learn first?
2. Best courses/certifications? I’ve looked at: Which are actually valued by hiring managers?
3. What roles should I target to break in? Regulatory Affairs Associate? Regulatory Operations? Quality/Compliance roles as a bridge? Clinical affairs?
4. How do I network effectively? Best ways to connect with RA professionals beyond cold LinkedIn messages?
5. How do I position my background? How would you frame national lab/postdoc + field applications experience so hiring managers see it as relevant instead of “just academic”?

I’m willing to put in the work and learn whatever’s needed.

Would really appreciate honest advice from anyone who has broken into RA from a technical/scientific background.

Thanks!

Suggest unique topic for mpharm regulatory affairs review article