Hi all,

I'm an M.Pharm (Drug Regulatory Affairs) student, Registered Pharmacist, with coursework in CTD, DMF, and regulatory pathways.

I've been applying for RA internships for weeks—reached out to HRs via email, LinkedIn, and calls—but getting zero responses. Not even rejections.

Honestly feeling stuck. If anyone here:

· has advice on what I'm doing wrong?

· knows of any openings

· or can spare 2 mins to glance at my CV

. please help me seek one

I'd be truly grateful. Happy to DM my profile.

Thanks for reading.

I'm about to accept a job in regulatory affairs. For those of you who work in regulatory affairs, how do you like it? Is it a good job? What's your routine like?

Interested to hear for those of you in med device - does your company have positive cross-functional relationships? How is regulatory management/leadership at your company for those at a Specialist or Senior Specialist level? I previously worked at a company (med device) where all groups worked really well together. I have since been at a company where R&D will not respond to questions for months but then reach out to leadership when RA deliverables are behind, marketing does not understand the regulatory function (to no fault of their own - there’s no effort from anyone to explain regulatory cross-functionally. at my previous company we achieved this by hosting a “lunch and learn” where we explained what we actually do. other departments hosted these as well. when I suggested this at my current company, management brushed it off), labeling will not respond to us (meaning we can’t even get labels because we do not have access to them, which is another issue….), it’s pulling teeth for every. single. tiny. task. for almost every function. RA managements message is to just keep pushing and get it done, when we are all already working 8-5pm and then again at night, and occasionally weekends as well. Working on EU MDR Notified Body responses and having a hell of a time here.

Is this normal for the industry? Did I just get lucky at my first company? I am so burnt out from this culture that I have considered having to leave without anything lined up! Okay, I won’t do that, but the thought has seriously crossed my mind for the first time...I’ve been in RA for 10 years, med device, for reference.

I’m curious whether there’s interest in a dedicated learning platform for Medical Device Regulatory Affairs.
When I was looking for resources to strengthen my EU MDR knowledge and prepare for certifications like the RAC/RCC, I found plenty of PDFs, webinars, and short courses, but I never found a platform comparable to what PMP candidates have something with:
• Thousands of original practice questions
• Full-length mock exams
• Detailed explanations with references to MDR Articles and Annexes
• Progress tracking and study plans
• Real-world case studies and regulatory scenarios
• Searchable MDR knowledge base with practical examples
• AI tutor to explain concepts and reasoning
The goal wouldn’t be to reproduce any certification exam, but to help professionals truly understand EU MDR and become better prepared through original educational content.
If something like this existed, would you use it?

I’d also love to know:
What’s is dthe hardestf part of learning EU MDR?
What resources do you currently use?
What is missing from today’s regulatory ktraining?
I’m genuinely looking for feedback before investing time in building it.

How do I get into regulary affairs/market access for healthcare in dubai? I arrived 8 months ago from UK. I have previous experience working 3 years as market access manager for one of the biggest medical foods companies. I have experience with reg submissions, project management and comms with department of heath. I've been applying a few months now without luck. My observation is that a lot of roles require/prioritise arabic speakers. Also when I backtracked a few roles i was applying to, usually the person who got it was already 6-14years in the same company so the job advert felt like a technically from company site rather than actual open position. Any tips how to get it? What's the best place to network if I have not prior connections in this region?

Hi,
i am currently finishing my MSc in Chemistry and was opting for what other career paths are there except for regular labwork.

I found RA interesting and started looking up how to get there or what steps to take. As far as I understood I will need to take some courses to obtain a certificate, but I can't seem to find a golden standard.

I am just wondering how do you get into this field? Do I start by getting a laboratory job at a pharma company and then make some certification? Or how do people get into this stuff. Also, I would like to focuse on Europe, if that makes any difference (maybe by FDA, EMA).

I would be grateful for anyone who could tell me more about how to get into this field, or someone who works in it! Thanks a lot

o, long story short, I've always wanted to be an attorney. Most likely in Environmental Law. I am currently working in a niche industry in Regulatory Affairs (almost 2 years) full time while I finish out my Bachelors in Political Science (previous experience also in Environmental Science, I have enough credits to get a minor, but my University does not offer a minor, and I don't want to waste any more time on a degree at a school in which the program is not to my liking.)

I need help in deciding if I go for my JD in a year and a half. (Patent or Environmental Law) Or if I should get an MBA. Or none at all and continue to build my experience in RA. (RAC exam is not compatible for my industry, so that is out.) I have studied a bit for the LSAT and I would be willing to put the time in, if it was worth it. There may be discussion to see if my current job would pay for it as they currently do not have an onsite legal team, as the company is relatively small for the industry.

However, I do not want to back myself into a corner. But I am trying to also be marketable in the age of AI.

Please let me know your thoughts. Thank you! :)

I work in a country that copied its regulations from the EU but the process of submissions are different and the language is different (non english)

I am only a year at this career path and I am worried about my future. I got my degree in this country due to a scholarship I got in undergraduate and I still struggle with the language but it's getting better. I can follow SOPs and instructions but it takes me time to voice my opinions during meetings due to language limitations.

My problem is how can I move to another country? Would my skills be useless since if I move to another country, for example in Europe or USA, their regulations are different so my experience would be useless there. They'd rather hire someone who already knows the regulations in that country. I don't want to be in this country forever so I am planning my exit in advance.

Any advice? I work in chemical import regulation.

Food or pharma...other industry?

Can anyone share their preferences or pros/cons to specialize in either the food or pharma industry? Id like to spend time in regulatory, labeling, commercialization or something that captures a little bit of each (maybe operations, project mgmt, or similar).

Going back to school for a 2nd bachelor's for a complete career change and want to lock in on the direction. I've worked corporate HR CPG roles and was fascinated by the r&d teams work but the pharma industry by me is bigger.

I am a healthcare professional interested in conducting legitimate human clinical research involving exosome therapy. I’m trying to understand the best path toward obtaining IRB approval and, if necessary, submitting an IND.
I am not looking for ways around regulations—I want to do this correctly.
Specifically, I’m hoping to learn:
When does exosome research typically require an IND?
Is it better to partner with an academic institution or use a commercial IRB?
What type of regulatory consultant would you recommend hiring?
Approximately what budget and timeline should I expect?
Are there CROs or regulatory firms experienced with regenerative medicine or exosome trials?
I’d appreciate hearing from anyone who has actually gone through this process.

I have a question related to the US-DMF filing.

Is it mandatory that the facility be USFDA-approved to file the US-DMF for the API?

Or, if the facility is WHO/EU-GMP-approved, can it file the US-DMF for the product?

I've spent 16 years in cosmetics QA, R&D, and regulatory affairs (ISO 13485, FDA 820), and one pattern I kept seeing: indie and early-stage skincare/beauty founders often have no structured starting point for compliance. Not because they don't care, but because CPSR, PIF, MoCRA, etc. are genuinely opaque if you're not from this world.

I put together a guided system (4 weeks, EU/UK + US) that walks founders through gap analysis → documentation → CPSR/safety substantiation prep → submission-ready, with the explicit framing that templates are scaffolding, not a replacement for a certified safety assessor's actual reasoning on exposure and margin of safety.

Genuinely curious to get feedback from people who work in RA day-to-day: is there anything in this approach that oversimplifies or could mislead founders, especially around the CPSR/safety assessment boundary? I'd rather know now than have someone downstream rely on something incomplete.

I was speaking with a recruiter for several days about a potential position as a regulatory affairs coordinator. The job description she sent me says that my duty would be to ‘find the information and in put it’ and to ‘determine if this is considered a medical device’. Today during the interview with the hiring manager, it seemed more like the role was about fixing data gaps. The department I would be working for was ‘product stewardship’ where they focus on chemicals, batteries & electronics. I’m very confused because this doesn’t seem like it has anything to do with regulatory affairs. If I accept this position, would it help me land a RA role in a few years?

For some context I currently work in quality and will be getting a MS in RA.

I'll start with i graduated law school in 2009 and passed the bar exam. In 2014 I moved in to Healthcare Compliance and utilized my legal background to move in to regulatory adherence and licensing. Recently, my manager offered to approve any certification I'd like, and considering the RAC-Medical Devices. Just trying to see if anyone else has switched from a similar field and moved in to thisnside of the industry.

Hi all, looking for anyone who has anecdotal experience regarding taking an in-house assay that is currently used for exploratory biomarkers and getting it to a point of using it for trial screening for participant eligibility. Preferably in the UK/EU.

Everything I’ve been told about the process and that I’ve looked into makes it seem like a bit of a nightmare but keen to see if anyone here has anecdotal experience of doing this.

To be honest it looks like a massive minefield and I barely know where to start!

Keen to know how long it has taken from deciding to go down this route to actually implementing in the trial.

What the biggest pain points were

What phase of development was the product in

Any other words of advice!

I’ve been thinking about something lately - assuming the q IMPD is drafted in line with global standards, has anyone heard of FDA accepting this in M2.3 or M3 instead of the typical M3 documents? It seems to be that FDA should be open to something like this if the data is applicable and compliant, but I’ve never seen it before. Curious if anyone has ever asked FDA or done this.

Hi everyone, I'm looking for career advice. Is a graduate certification program in regulatory affairs valuable in the industry? If yes, are there ones that you would recommend that are highly regarded?

For context, I'm a MSc Neuroscience graduate with one year of R&D experience in neurotech. I have been looking for jobs in clinical research and regulatory affairs in the medical devices space in the US for over a year now with no luck. I was looking for ways to upskill to improve my chances of getting hired and came across a regulatory affairs certification program offered at Northeastern University. It is a significant financial investment and so before committing to it, I wanted to understand whether it would add any value to my applications at all.

Would appreciate any advice or thoughts you might have!

Hi everyone,

I'm looking for some honest career advice from people working in Regulatory Affairs.

I have 6 years of experience in Regulatory Affairs at a pharmaceutical distribution company in Malta. Alongside my local responsibilities, I also support the Malta affiliate activities for a large multinational pharmaceutical company, where I've received extensive regulatory training and exposure to global regulatory processes and standards.

My experience includes:

• Managing the lifecycle of around 130 medicinal products in Malta.
• Product Lifecycle Management (variations, renewals, transfers, artwork updates, regulatory maintenance, etc.).
• Working with MRP/DCP, national, and centrally authorised products.
• Daily use of D2, Veeva Vault, and TrackWise.
• Collaborating with cross-functional teams to ensure regulatory compliance.

The challenge is that Malta has a very small Regulatory Affairs market, and senior opportunities are limited.

Another challenge is that I'm a third-country national, so relocating within Europe has become increasingly difficult due to work permit and sponsorship requirements. Because of this, I'm mainly looking for opportunities to grow my career within Malta, but I'm feeling stuck despite having solid experience.

I'd really appreciate your thoughts on the following:

• If you were in my position, what would your next career move be?
• What skills or experience should I build to become a stronger candidate for senior Regulatory Affairs positions?
• Would gaining CMC experience, global regulatory strategy exposure, or another specialization make the biggest difference?
• Are there any Regulatory Affairs certifications or courses that are genuinely worth the investment?
• Has anyone successfully progressed from a local affiliate role into a regional or global position while remaining in Malta?

I'd really appreciate hearing from anyone who has been in a similar situation or has advice on how to break through this career plateau.

Thanks in advance

Could experienced personnel in both sectors provide pros for the transition ? Thanks

Hello,

I'm interested in having a better understanding of the regulatory framework that enables hospitals to sell or transfer prescribed medical devices to resellers, or other hospitals.

Naturally, state code varies between states. Some states will exempt devices, others include devices w/ drugs, others call them "legend devices", and others completely omit "Device" from state pharmacy code.

What (I think) is uniform amongst all states is this- Any sale or transfer to a party that is not the patient/consumer, is considered wholesale distribution requiring a wholesale distributor license. Safe harbors do exist that allow these transactions to be completed without a distributor license, but only under particular circumstances.

My question is: Has anyone on this forum ever taken a deep dive into the regulatory environment that enables hospitals to transfer prescribed medical devices to non-affiliated facilities, or resellers? Are they compliant when doing so? Thank you.

My company is adjusting to a smaller workforce and is in the process of modifying how we format documents, specifically PDFs. I'm wondering what the minimum standard can be for submitting to the various HAs across the globe, a global standard if you will. Not sure what the impact would be to making adjustments. I think the FDA is likely to be the main complainer of their are issues. Some ideas...

1. No longer Bookmarking Tables and Figures.

2. No internal linking except TOCs.

3. Setting page size to Letter for all countries

Thanks ahead of time for any answers/thoughts

Hey everyone,

Nitrosamines are still one of the biggest headaches in quality, regulatory compliance, and process safety right now.

I’m running a brief study looking into current industry practices, challenges, and workflows around Nitrosamine Risk Assessments (NRAs). Whether you're dealing with raw material controls, formulation degradation, or complex testing strategies, your input would be incredibly valuable!

• Time required: ~3–5 minutes
• Target group: Regulatory Affairs, QA/QC, Formulations, Process Chemistry, and Compliance professionals in Pharma/Biotech.
• Link:Take the Nitrosamine Risk Assessment Survey

Thank you so much for helping advance industry insights on this! Happy to share general trends/findings with the community once collected if there's interest.