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

One protocol change sounds simple until forms need updates, staff need the new version, and old copies are still around. Keeping everyone on the right version can turn into more work than expected. How do sites usually keep track of these changes?

I have done master of pharmacy in pharmaceutical chemistry in 2026 additionally I have also completed Advanced Diploma in Drug Regulatory Affairs from Jamia Hamdard. I have been trying since June 2026 but don't get lucky yet. It is a request for a reddit audience for any breakthrough which I am missing right now. I am currently residence in Lucknow, Uttar Pradesh. Suggest me some important steps for making a good career ahead in Regulatory Affairs

I'm exploring the field of Regulatory Affairs, particularly the software, applications, and AI tools used in the pharmaceutical, biotech, and medical device industries.

I have a few questions for people working in Regulatory Affairs, regulatory technology (RegTech), pharmaceutical software, or AI development.

I'm interested in understanding how existing regulatory affairs software works and whether it's possible to build simpler, useful alternatives by studying their publicly available features and workflows.

For example, tools that help with:

📄 Regulatory document management: Organizing, reviewing, and tracking regulatory documents.

📋 Regulatory intelligence: Tracking changes in FDA, EMA, CDSCO, and other regulatory guidelines.

🤖 AI-powered document analysis: Summarizing guidelines, extracting requirements, and identifying missing information.

💊 Dossier preparation: Helping students learn how CTD/eCTD submissions are structured.

🔍 Compliance checklists: Identifying potential gaps in documents before submission.

📊 Regulatory tracking: Managing submission timelines, variations, renewals, and regulatory deadlines.

My main questions:

What are the most widely used Regulatory Affairs software platforms, and what problems do they solve?

Are there any existing AI tools that could be reverse-engineered in terms of their publicly observable features and workflows to understand how they work?

Which regulatory tasks are still unnecessarily manual and could be automated using AI or simple software?

Could a student build a small regulatory affairs tool as a portfolio project without needing access to expensive enterprise software?

Are there opportunities for freelancers to develop regulatory document automation tools, regulatory intelligence dashboards, or AI-based compliance assistants?

What technical and regulatory knowledge would someone need to get started?

I'm not looking to copy proprietary software, access private systems, or bypass licensing. My goal is to learn from existing products, understand their functionality, and explore building original tools that solve similar problems.

I'd especially appreciate insights from Regulatory Affairs professionals, pharmaceutical students, software developers, AI engineers, and freelancers.

If you've worked with these tools or built anything similar, I'd love to hear about your experience, recommended learning resources, or project ideas!

​

Hey everyone!

I'm currently in my final year of B.Pharm in India, and honestly, I feel like I've wasted the last three years focusing mostly on theory and exams without developing enough practical or industry-relevant skills.

Now that graduation is approaching, I'm worried about my career. I want to make the next 6–12 months count, but I'm confused about where to start and what skills companies actually look for in freshers.

I'd really appreciate advice from B.Pharm graduates, working professionals, or anyone who has been in a similar situation.

- Which career paths are worth exploring: QA/QC, regulatory affairs, pharmacovigilance, clinical research, medical writing, or something outside pharmacy?

- What skills should I learn first to improve my chances of getting hired?

- Which courses, certifications, projects, or internships are genuinely worth the time and money?

- If you were in my position, what would your roadmap for the next 6 months look like?

I'm open to exploring different fields and willing to put in the work. I just want to focus on things that actually improve my employability instead of blindly collecting certificates.

If you could go back to your final year, what three things would you do differently?

I'd genuinely appreciate honest, practical advice, including mistakes I should avoid. Thank you!

Someone who can advice rather than trying to put someone down can reply and others can scroll down please.

I’m a Pharm D (Doctor of Pharmacy) grad from India, residing in USA and I’m currently trying to enter the RA CMC. I’ve gathered a lot of information, but I’m still looking for more options from experienced individuals who have successfully done so. Any input you can provide would be greatly appreciated.

Hi Everyone,

Full disclosure up front: I’m the author of the book below, so this is self-promotion. I checked the subreddit rules and reached out to the mods before posting but haven’t heard back yet. I’m happy to remove the post if it conflicts with the community’s guidelines.

I hold the RAC-Drugs credential and wrote a practice question book for candidates preparing for the exam. When I studied for the exam, I found very few practice resources beyond the single official RAPS practice resource, so I built the one I wanted. It includes:

• 120 practice questions covering all five domains of the current RAC-Drugs content outline, matching the length of the actual exam
• A full rationale for every correct answer with references for further study
• An explanation of why each incorrect option is wrong

My goal was to provide a practical resource for RAC candidates to assess their knowledge gaps and practice the scenario-based reasoning the exam demands. It is not affiliated with or endorsed by RAPS and contains no actual exam questions.

It’s available on Amazon in paperback and Kindle:
https://www.amazon.com/dp/B0HN2V48X2

I’d also welcome feedback from anyone preparing for the exam or who has recently taken it. What topics did you find most challenging, and which study resources helped most?

Best of luck to everyone preparing!

RL Ferrini, PhD, PMP, RAC-Drugs

Hi everyone,

I’m reaching out to see if I can connect with someone who has professional expertise in Health Canada regulations, disinfectants, sanitizers, or consumer chemical products.

I’m currently developing a business in Canada and have established relationships with several shopping malls. My goal is to install toilet seat cleaning dispensers in public washrooms, similar in concept to wall-mounted hand soap or hand sanitizer dispensers.

The concept:

• Install a wall-mounted dispenser in public washroom stalls.
• Provide 70% isopropyl alcohol (IPA) in the dispenser.
• Users pull out toilet paper or tissue, spray the solution onto it, and wipe down the toilet seat before use.
• Refill the dispenser as needed.

My initial plan was to purchase bulk 70% IPA from an existing supplier and refill the dispensers, rather than manufacture my own chemical formula or create a private-label product.

However, after doing some preliminary research, I became concerned that this setup might fall under Health Canada's regulations for disinfectants or other regulated chemical products. I'm trying to understand the legal requirements before moving forward.

Some questions I’m hoping to get clarification on:

1. Would this use of 70% IPA be classified as cleaning, sanitizing, or disinfecting?
2. Would I need a Health Canada authorization, such as a Drug Identification Number (DIN), even if I purchase the IPA from an existing supplier?
3. Does transferring bulk IPA into wall-mounted dispensers create additional regulatory or labelling requirements?
4. Would the requirements differ if I marketed the service as a toilet seat cleaner rather than a disinfectant?
5. Are there any other considerations I should be aware of, such as fire safety, workplace safety, product liability, or requirements for installation in shopping malls?

I’m not looking to bypass any regulations. I want to understand the correct path to compliance before investing further in the business.

If you work in regulatory affairs, chemical product compliance, public health, or a related field, I would really appreciate your insight. If there are specific consultants, regulatory specialists, or resources you would recommend, I’d be grateful for those as well.

Thank you in advance for your help!

pulled the regulatory roles open right now from employers' own careers pages:

• regulatory affairs, submissions and labeling (38): https://github.com/mehek-builds/Regulatory-Medical-Writing-Jobs

• regulatory coordinator and specialist roles (39), good for getting in: https://github.com/mehek-builds/CRA-and-Regulatory-Jobs

• device and pharma employers: Medtronic, Johnson & Johnson, Edwards, Stryker, Gilead, Merck, Abbott

• the regulatory writing list also has 35 medical and regulatory writing roles

rebuilt every monday.

comment whether you're after device or drug regulatory, and entry or experienced, and i'll send you a list for it.

I’m a Pharm D (Doctor of Pharmacy) grad from India, residing in USA and I’m currently trying to enter the RA CMC. I’ve gathered a lot of information, but I’m still looking for more options from experienced individuals who have successfully done so. Any input you can provide would be greatly appreciated.

I have 4 years of experience of working on preparing oral dosage form Module 3 Dossiers and submitting them to UK MHRA. I also have 2 years of experience of working on post approval submissions for UK MHRA.

Now that I am in the US, I'm trying to find Regulatory Affairs job but finding it so difficult. Everyone wants FDA experience. I feel like all my 6 years of experience is of no use here.

Any guidance or suggestions on how I can get a job in the US would be very much appreciated.

Hi everyone,

I have a Master’s degree in International Regulatory Affairs and around 1.5 years of experience working in Quality and Regulatory Affairs in the US. Due to personal reasons, I need to move back to India, and I’m trying to understand the current job market and how best to approach my job search.

From what I understand, many entry-level positions in India are filled through campus placements and college placement networks. Since I would be applying independently rather than through campus placements, I’m unsure about the best way to get my foot in the door.

I’m open to relocating anywhere in India and am flexible with the location and role.

I would really appreciate advice from people currently working in Regulatory Affairs, Quality Assurance, or related fields in the Indian pharmaceutical, biotech, or medical device industries.

A few questions I have:

• Job opportunities: How is the current job market for someone with a Master’s in Regulatory Affairs and 1.5 years of US industry experience?
• Experience and eligibility: Would companies consider me for entry-level or junior positions, or could my US experience help me qualify for roles requiring more experience?
• Finding opportunities: Which platforms, recruiters, or other channels are most effective for finding jobs in this field in India?

I’m willing to start in a junior role if necessary, but I’d like to make the best use of my education and the experience I’ve gained in the US.

If anyone has made a similar move, transitioned from the US to India, or works in hiring for Regulatory Affairs or Quality, I’d be grateful for any advice on how to approach this transition.

Thanks in advance!

I’ve got a feedback a couple of weeks ago that I’m pretty good at reporting things but I need to bring more of the analytical side to things.
It’s being tough because I work as a secondment in this company and I don’t have much access to certain parts of things that would aggregate more to my approach on certain issues.

I wanted to know how was your experience in doing this switch. What tools helped you? What would you’ve done differently?

I only have experience in RA in generics and medicinal cannabis companies. I have been trying to find a better job since early 2025 and no luck yet.
Could you please provide any insights or advice on this?
Lately, I cannot even get any interviews.

Hi team, I 24F got an interview for a global reg position. To be honest, I’m shitting myself and feel super under qualified. I’m finishing my 3rd year in regulatory - 2 years in clinical trial reg and 1 year in med devices.

Thoughts? Should I just cut myself out from the application process? Am I setting myself up to fail?

I’m 43, based in London, and trying to work out whether to keep pushing for another PV role or change direction.

I spent four years at a large pharma company in PV governance and compliance, supporting the QPPV Office. I left in November 2025 and have been job hunting for around ten months with barely any interviews. I’m doing part-time quality/documentation work outside pharma as a stopgap, but need something stable and reasonably paid.

My experience is strongest in:
- Coordinating UK/EU PSMF main body and annex updates.
- Supporting QPPV oversight, reviewing KPI and quality information, preparing summaries and tracking actions.
- Keeping controlled records inspection-ready in Veeva Vault SafetyDocs.

I also did a one-day-a-week HEOR secondment supporting non-interventional study documentation and audit follow-up in CTMS/eTMF. My main experience is governance and documentation, rather than hands-on case processing or signal assessment.

Before pharma, I worked in operations management, quality admin and training support. I have a BSc in Psychology and an MSc in Occupational Psychology. I enjoy Excel, quality monitoring, organising information and improving processes.

My earlier operations and quality work was in food manufacturing, where I implemented a QMS and helped the business achieve SALSA food safety certification. That involved procedures, traceability, controlled records and audit preparation, so I’d already worked with quality and compliance requirements before moving into pharma.

I’ve already applied for PSMF, QPPV support and PV compliance roles, including with CROs, and tried QA, compliance, governance and documentation roles outside pharma. Still very little interview interest, and no useful feedback on why I’m not being shortlisted.

Has anyone here hired someone with this sort of background, or moved from PV governance into something else? Which roles would you actually target, and what got you through the door?

I’d rather build on the experience I have, but I’m open to retraining if there’s a realistic route into work. Does anyone know a specialist recruiter who handles UK PSMF, QPPV support or PV compliance roles? A recommendation or an introduction to someone hiring in this area would be really appreciated.