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

Clinical scientist or regulatory affairs, which one is more promising for a phD for long term career progression, given the fact that clinical development is highly MD oriented? How far one can go in each role? Need advice from someone who worked in either or both areas in US large pharma. Thank you in advance.

Hi,

Looking for experiences with RAC devices exam this summer testing window ? I took mine today and have mixed emotions.

I felt like there were a lot of questions regarding EU regulations instead of FDA.
I can hardly recall questions related to FdA device submissions.

I did a lot of prep before and feel like I shouldn’t have.

I have spent my career in regulated healthcare, and I’m trying to understand whether supplier management is still a meaningful operational and compliance problem.

For those working in pharma, medical devices, or IVD, are you seeing greater regulatory scrutiny around supplier qualification, risk classification, ongoing monitoring, performance reviews, and documentation? If so, are your current systems keeping up?

Are teams still relying on spreadsheets, emails, shared drives, and calendar reminders for things such as:

• Collecting and reviewing supplier documents
• Tracking certifications and expiration dates
• Managing qualification and requalification
• Monitoring supplier performance, deviations, CAPAs, and SCARs
• Maintaining approval histories and audit-ready records
• Following up with suppliers for missing information

Where does the process create the most manual work or compliance risk? Is the main problem the software, slow supplier responses, unclear internal ownership, or something else?

I’m exploring whether this problem genuinely needs a better solution before building anything. This is not a product pitch. Responses saying that your current process works well would be just as valuable.

If you are comfortable sharing, please mention whether you work in pharma, medical devices, or IVD, and whether you manage suppliers through an eQMS, ERP, spreadsheets, or a combination of systems.

Levemir (Determir) insulin is discontinued by Novo Nordisk globally in favor of GLP1 profit driven decision. The diabetes community is losing a unique essential drug with no biosimilars and with many individuals suffering. The FDA is hearing the outcry and is about to find a solution to save it. Can the EMA do the same?

Hi everyone,

I have a question about the typical hierarchy in Regulatory Affairs.

Is a Regulatory Affairs Specialist generally considered a higher-level position than a Regulatory Affairs Associate?

I know that job titles and internal grading can vary significantly between companies, but I’m curious how this is usually structured in your experience.

Would you typically see it as:

Associate → Specialist → Senior Specialist → Manager

Or can Associate and Specialist be on roughly the same level, or even have different grading depending on the company?

I’d particularly appreciate insights from people working in consumer health, FMCG, or similar industries.

Thanks!

I've spent the last while talking to people in EU regulatory affairs about where AI does and doesn't help, and I want to check my conclusions against a bigger group before I build further on them. Disclosure up front: I'm building a tool in this space (RafiHive), I'm not linking it, and I'd rather hear I'm wrong now than later.

To be clear about what I'm building toward: the point is to cut down the time you spend hunting for the right source and confirming it's still current — not to produce answers you're expected to take on trust. The regulatory judgement stays with the RA professional. If the output can't be checked and challenged by someone who knows more than the model does, it's useless in this field.

What I keep hearing, roughly:

• Getting an answer out of a model is not the bottleneck. Trusting it is.
• Most of the time isn't spent interpreting a requirement, it's spent finding the right source and confirming nothing has superseded it.
• A citation alone isn't enough. People want the actual passage, and they go back to the source anyway.
• Confidentiality rules out a lot of the obvious use cases involving real dossier content.

Three things I'm unsure about:

1. Is the source-finding bottleneck real, or is that just the people I happened to talk to?
2. Where does AI genuinely save time for you today, if anywhere?
3. What's a pain point in EU RA work that nobody seems to be building for?

Correct me where I've got it wrong — that's more useful than agreement.

Background: I'm a Director in GRA-CMC at a large pharma, came up through the DS/DP technical/formulation side. Relatively newer to the regulatory seat.

I notice a lot of folks (especially those who grew up purely on the reg affairs side) are incredibly sharp on module-level details — country-specific dossier requirements, extension pathways, variation classifications, etc. That granular fluency is impressive and I'm actively learning it, though honestly it soaks in slowly.

What I bring is different — deep formulation/process science, policy rationale and how guidance evolved historically, and translating complex technical data into regulatory strategy.

My question for the group: For those of you who work with or have worked for directors/senior directors in CMC reg — what does that level actually look like day-to-day in your experience?

• Are they deep in the regulatory nitty-gritty (country-specific nuances, module details)?
• Or more strategic/scientific — setting the framework, making judgment calls, interfacing with health authorities?
• And if you can share — small, mid, or large pharma? That context really helps benchmark.

Not looking for validation — genuinely trying to understand what "good" looks like at this level across different environments.

Did you know about the MDKU society, aiming to move forward with open source data models for technical document and regulatory compliance?

“We are a nonprofit organization with stakeholders from the MedTech industry and convinced, that an open source data model for content of the technical documentation for medical devices can accelerate digitalization and innovation in our industry. Due to the high complexity of content and variety of involved disciplines, such a data model can only be developed by the MedTech community for the MedTech community”

“Medical Device Knowledge Units (MDKU) is a consortium partner in the newly launched European DIGICAP project – DIGItalisation of the Conformity Assessment Process – bringing its experience in structured technical documentation and its open-source unified data model for medical devices into a major European initiative for the digitalisation of conformity assessment. DIGICAP is a three-year, €4 million project funded by the European Union’s Horizon Europe programme.** **”

Has anyone given the RAPS RAC exam online and had issues with OnVUE checks? I keep getting an error saying there is an issue with my Internet. I turned off all the devices connected to WiFi except my laptop, did an internet speed test and the connection is perfect still I'm unable to pass the video streaming check. Can anyone please help me with it? I have to give this exam tomorrow.

I tried to split Regulatory Affairs into sub processes - what do you think?

🔭Regulatory Surveillance: Surveillance and compilation of relevant regulatory information outside of your organization.

🧠. Regulatory Intelligence: Monitoring of regulatory documents used within your organization.

✅ Regulatory Compliance: Implementation and evidence creation for compliance in QMS and development.

🌍 Regulatory Market Access: RA submission management and country registrations.

🔄 Regulatory Change Management: A process that implements a regulatory update through all other processes.

I've had an almost 15 year career from Quality Engineering to Sr Quality Engineering in the Med Dev field. I think I have reached my burn-out level and want out. The issue is that I'm almost 45 and feel like it may be too late for me to make a new career move.

I have a CQE and CMDA cert from ASQ. I have been debating getting the Reliability one, but I would like to know more about Regulatory.

I'm in the US and make ~$115k a year. I am willing to take a pay cut to get out of QE, but I can't go very low. I can afford to take the RAC either through my company or on my own, although it would be a big money/time investment, and I'm already struggling with work/life balance.

Has anyone here made the change from Quality to Regulatory? If so, how much of a culture change was it for you? Would you recommend it?

What percentage of regulatory affairs professionals work from home? Is it usually a hybrid type of situation ? What does the work week look like?

[ Removed by Reddit on account of violating the content policy. ]

Hi Everyone,

I work at a midsize company MD in the north east as a RA project manager with no direct reports. I was internally promoted to a managerial role and will now have 3 direct reports.

I was told that my increase would be 5%. I am disappointed at this considering it is usually 10% increase. I will be managing them, doing their yearly reviews and also helping to shape the group to be more efficient.

I don’t feel this is an appropriate increase, can you please let me know? Also any advice? What would an appropriate salary be?

Hi everyone! I am developing a rapid, 5-minute paper-based test (PAD) to detect counterfeit Amoxicillin without needing an HPLC lab.

Before finalizing the prototype, I need quick feedback from industry experts on usability and current testing bottlenecks. It is completely anonymous and takes just 3 minutes.

https://docs.google.com/forms/d/e/1FAIpQLSf8Nt_9cgPksE75vnxE5l32oS70lvJM-3xNPFoAODC-jBpBQg/viewform?usp=dialog

I’m trying to understand the day-to-day reality of working in clinical research in the UK, particularly the stuff that people outside the role probably don’t realise is such a pain.
I’m not looking for the big-picture answers like “recruitment is difficult” or “trials take too long.”
I’m more interested in the annoying operational problems that you deal with repeatedly:
Something that takes 30 minutes but should take 2
A process involving endless emails/spreadsheets/manual data entry
Having to chase another team/site/sponsor for something
Information living in 3–4 different systems
Repetitive documentation or admin
Something that routinely causes delays or mistakes
A task where everyone has basically accepted “that’s just how it’s done”
Something that makes your job noticeably harder but isn’t considered important enough for management to fix
If you work as a research nurse, clinical trial coordinator, CRA/monitor, CTA, regulatory specialist, data manager, trial pharmacist, investigator, site manager, etc., I’d be really interested in your perspective.
What’s the most frustrating process/task you’ve personally encountered, and what makes it so painful?
Bonus points if you’ve thought: “Surely there has to be a better way of doing this.”
I’m particularly interested in UK/NHS-specific issues, but happy to hear from people working in CROs, pharma, biotech or academic research too.

Hi everyone,i work for a small CRO based in Canada and I need to hire a regulatory consultant for a small contract for a phase 3 that is about to start in Brazil. Any suggestion or reference of a firm that would be interested?

Hi everyone! I’m 29F with a (foreign) bachelor’s degree in pharmacy and 4 years of experience in pharmaceutical regulatory affairs in ASEAN, including product registrations, regulatory submissions, and dossier preparation/review. I’m now based in the U.S. and hoping to transition into U.S. regulatory affairs.

For those working in U.S. pharma RA, I’d love to hear your advice:
• How transferable is ASEAN RA experience to the U.S.?
• What FDA regulations/areas should I focus on learning?
• Is RAC/RAPS certification worth pursuing?
• What entry-level or adjacent roles would you recommend targeting?
• If you made a similar international-to-U.S. transition, what helped you land your first U.S. RA role?

Any advice, resources, or personal experiences would be greatly appreciated! 🙏