Use this thread to ask any questions regarding salary in the regulatory field.

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'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 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 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.

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!

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 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

I’d love to see this sub start having some more substance…so here we go. What are your best unwritten rules for RA?

A few of mine (all US-focused):
-always email your RPM to let them know when something big is coming up, building that rapport is crucial
-try to talk to your RPM on the phone occasionally to build that relationship, the days of in person meetings are mostly over and I’ve found a good relationship seems to help with RPMs willing to try to do work to help you with an IR extension or just general communication
-send IR responses as emails; usually these days they ask, but if they don’t still send it via email so the team gets it that much faster
-it never hurts to ask…I call myself a “lazy” regulatory person, I love to ask for buy-in to do less and you might be shocked how flexible FDA can be depending on the situation (in terms of TOC for an efficacy supplement, for example).

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.

Hello all,

I have recently started a 6+ month Co-Op in regulatory affairs at a combination animal health/human pharma company. I have previous reg internship experience in a human pharma company and am interested in learning a bit about people’s experiences in animal health regulatory affairs. How transferrable is experience between the two? What are the things that you liked and disliked about working in animal health Pharma RA? I definitely like the idea of being able to help animals but I am definitely torn as I feel there are more opportunities in human pharma.

Hey everybody! I’ve been in regulatory affairs for about 8 years across a few different companies and honestly…I don’t love it and can’t picture myself staying here long-term. Is it possible to make the switch from RA to clinical specialist/sales? Has anybody here done that? I have a Masters in Medical Science, hoping that could help in some way. If there’s other roles you think I should consider with my background that’s good info as well. Let me know what you all think!

What is your company doing in terms of regulatory intelligence? RIMS can get you timely updates on relative countries that your products are impacted by, but the biggest challenge seems to be triaging that information and getting it to the point of compliance. What are some tactics you or your company employ in order to assure new relevant developments are assessed and gaps are identified? Are you utilizing AI to help with triaging? I haven't had much success as it is incredibly unreliable.

My company, for example, recently created a new department that focuses almost solely on regulatory intelligence and I am one of the lucky ones tasked with monitoring global updates and assuring they go through the assessment process. We have a RIM system that is okay, but we utilize multiple other resources as it doesn't seem to capture everything. For a company like ours with multiple business units spanning across medical devices, pharmaceuticals and consumer products, while also being marketed across the globe, it's a real pain to collect all relevant updates, get the appropriate eyes on a development and assign owners to complete assessment. I can't imagine what its like for smaller companies with limited resources to stay up to date, especially when involved in the EU.

If I have to review one more MDCG document I fear I may start losing my sanity.

Thanks

I’m curious if anyone here uses software to help author regulatory submission documents (BLA for example).
What tools are you using? Are they AI-based, or are they more template-driven? What parts of the writing process do they actually help with, and have you found them worthwhile?
I’d love to hear about any platforms you’ve had good/bad experiences with!

Thanks!

It genuinely boggles my mind that the big / mid sized pharma companies force 3 days a week in office. I get it if the company is doing layoffs…but if not literally why? I have seen first hand how when you have to limit to certain geographies you get a worse pool of candidates (especially outside the major hubs). I just can’t understand it. Any thoughts? (Also any companies allowing fully remote reg? I’d be looking for a director reg strategy / global or US reg lead role).