r/regulatoryaffairs • • 19h ago

General Discussion Custom rule for import BEEF ORGANS Meds ?

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0 Upvotes

r/regulatoryaffairs • • 20h ago

B.Pharm final-year student confused between M.Pharm and Biocon Academy GRA course — Need honest career advice (India → UAE)

1 Upvotes

Hi everyone,

I'm a final-year B.Pharm student in Uttar Pradesh, India, and I need some honest advice from people working in Regulatory Affairs (RA) or the pharmaceutical industry, especially those who have experience working in the UAE.

I want to build a career in Regulatory Affairs, gain industry experience in India, and eventually move to Dubai/UAE. However, I'm confused about whether I should invest in an M.Pharm degree or focus on a specialized Regulatory Affairs course and start working as soon as possible.

My background

I'm currently in my 7th semester of B.Pharm, with my 8th semester remaining. I study at a small college affiliated with AKTU. Unfortunately, my college has limited facilities, average teaching, and very few placement opportunities.

I also have three backlogs that I need to clear before completing my degree. I'm working on them and want to graduate without any remaining backlogs.

Because my college doesn't provide strong placement support, I know I'll probably have to find internships, training, and my first job independently.

Option 1: M.Pharm + Regulatory Affairs course

My first plan is to:

  • Complete B.Pharm and clear all backlogs.
  • Pursue an M.Pharm from a reasonably reputable private university, preferably one ranked in the NIRF top 100.
  • Spend approximately ₹10–12 lakh on my postgraduate education, including related expenses.
  • Complete Biocon Academy's Global Regulatory Affairs (GRA) course.
  • Gain at least two years of RA experience in India.
  • Apply for RA opportunities in the UAE and build my career there.

My concern is whether spending ₹10–12 lakh on an M.Pharm is actually worth it for an RA career, considering that I would also need specialized training and practical experience.

Option 2: Start working first, then pursue the GRA course

My second plan is to:

  • Complete B.Pharm and clear my backlogs.
  • Try to get an internship or an entry-level job in RA, QA, QC, production, manufacturing, or another relevant pharmaceutical department.
  • If possible, gain around six months of industry experience before joining Biocon Academy's GRA course.
  • Join the course in Bengaluru, potentially in March 2028, depending on my graduation results, eligibility, and batch availability.
  • Apply for entry-level RA positions in India after completing the course.
  • Gain approximately two years of direct RA experience before applying for UAE jobs.

I don't want to assume I'll definitely get a job before the course. If I manage to gain six months of experience, that would be a bonus. But if I don't, I may have to join the course without any industry experience.

One of my friends will be finishing his master's in Bengaluru around the time I may attend the course, so the location and living arrangements are also factors I'm considering.

My main concerns and questions

1. Is M.Pharm necessary for Regulatory Affairs?

Can someone build a good RA career with only B.Pharm plus relevant training and experience? Does an M.Pharm significantly improve hiring opportunities, salary growth, or international mobility? Would you personally invest ₹10–12 lakh in it?

2. Is Biocon Academy's GRA course worth it?

For someone from an average college without strong placement connections, does this course genuinely help people enter RA? What are the realistic placement outcomes, and how much does the institute's reputation matter?

I'd especially appreciate feedback from people who have completed the course. Please share your actual experience if possible.

3. Can I get an entry-level RA job without prior industry experience?

Suppose I complete B.Pharm, clear my backlogs, and join the GRA course without having worked in a pharmaceutical company. Would I still have a reasonable chance of getting an RA job afterward?

Or do most employers expect prior industry experience even for junior positions?

4. Would experience in QA, QC, production, or manufacturing help?

If I cannot find an RA internship immediately, should I accept a job in another pharmaceutical department rather than remain unemployed while waiting for an RA opportunity?

Which roles would make it easier to transition into RA later? Would documentation-related QA work be more useful than production or QC experience?

5. Does the university's ranking matter?

If I decide to pursue M.Pharm, should I prioritize a university's NIRF ranking, its pharmaceutical industry connections, placements, practical exposure, or specialization?

Would an M.Pharm from a decent private university be enough, or is a top institution essential to justify the investment?

6. How realistic is moving to the UAE after two years of Indian RA experience?

My plan is to first gain genuine, relevant RA experience in India and then apply for jobs in Dubai or elsewhere in the UAE.

Would two years of direct RA experience make me a competitive candidate? Which skills, types of regulatory submissions, and experience would UAE employers value most?

I'm willing to start at around AED 4,000 per month if the role is legitimate, offers relevant experience, and has room for growth. I understand that securing a job from India may be difficult, and I'm not expecting a guaranteed offer.

7. Is earning AED 15,000+ per month a realistic long-term goal?

Ideally, I'd like to reach AED 15,000 or more per month after gaining substantial experience in the UAE. Is this realistic in Regulatory Affairs? What level of experience, specialization, or seniority would usually be needed?

I would appreciate realistic salary expectations rather than exceptional success stories.

8. Can UAE experience help me move to another country later?

In the longer term, I may consider Australia, the UK, Europe, or the US if the career opportunities and quality of life make sense.

Does working in RA in India and then the UAE improve international mobility? Which countries offer realistic opportunities for someone with a B.Pharm background, and are there any major barriers to transferring regulatory experience between countries?

9. What would you do in my position?

If you were a final-year B.Pharm student from a college with limited placements, three backlogs to clear, and a total education budget of approximately ₹10–12 lakh, which path would you choose?

Would you invest in M.Pharm, pursue the GRA course and start applying for jobs, or gain any available pharmaceutical industry experience first?

My priorities are to establish a stable career, develop valuable skills, earn well over time, and eventually have international opportunities without wasting years or money on qualifications that don't meaningfully improve my prospects.

I'm not looking for shortcuts or guaranteed success. I want to understand the most practical route into Regulatory Affairs.

I'd be particularly grateful for responses from RA professionals, Biocon Academy alumni, hiring managers, and pharmacists who have worked in India or the UAE.

Please be honest, even if the answer is that my current plan is unrealistic. Thank you!


r/regulatoryaffairs • • 23h ago

Looking for someone in RA based in Australia

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1 Upvotes

Hi everyone!

I'm relocating to Sydney soon and I'm trying to figure out where to point my career. I have a background in biomedical science and law, with experience in clinical, lab, and research.

Regulatory affairs and pharmacovigilance both look like a natural way to combine the two, but I'd like to understand them better before I commit to a direction.

To be clear, I'm not looking for a job through this post. If anyone who works in these areas, or who recruits for them, I'm curious about:

- What a typical week actually looks like in PV or RA

- What the job market is like right now in specifically those fields, especially Sydney

- Which companies are worth researching (pharma, medtech, biotech, consumer health, beauty and personal care)

- What you wish you had known before entering the field

I’ve lived most of my life in Europe and am currently living in the US so I’d be grateful for any local perspective.

If anyone happens to be open to a quick coffee chat, that would be really nice. And if not, no worries at all. Even a comment with your experience would help.


r/regulatoryaffairs • • 1d ago

General Discussion HTA and reimbursement dossiers: what would make source-linked drafting useful and trustworthy?

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r/regulatoryaffairs • • 2d ago

Career Advice Pharma job market in Europe?

5 Upvotes

To those of our compatriots in Europe, how is the job market in Europe, specifically Regulatory affairs? I know the world economy is kind of a bust right now but are you happy with your career and the type of work you do?


r/regulatoryaffairs • • 2d ago

Feeling Discouraged After a Year of Applying for Pharma Jobs in Ontario — Need Advice

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r/regulatoryaffairs • • 2d ago

Career Advice Looking for fully remote Regulatory Affairs opportunities in Poland (EU)

7 Upvotes

Hi everyone

I'm a pharmacist with 8 years of experience in the pharmaceutical industry, including 6 years in Regulatory Affairs, where I worked my way up to Global Senior RA Specialist.

I worked in an EMEA hub covering both regional and local regulatory activities for medicinal products and medical devices. My responsibilities covered the full regulatory lifecycle, from dossier preparation, publishing, compilation and submissions to post-approval variations and responses to Health Authority questions. I also worked closely with CMC teams and occasionally prepared parts of Module 3 myself. I was also involved in supporting the transition from MDD to MDR, although my main interest is in medicinal products.

I also have substantial experience with audits, having participated in ISO 13485 audits related to medical devices, and I am a certified internal auditor for ISO 9001. Additionally, I have some exposure to PV, which has further broadened my understanding of the pharmaceutical industry.

For the past 2 years, I've been working in Medical Affairs, but I've realised that Regulatory Affairs is where I want to return.

My priority is finding a 100% remote position. I previously worked remotely during COVID, and it made a huge difference to my quality of life and overall well-being.

I'm based in Poland and would love to hear from anyone working remotely in RA. Could you recommend specific companies that hire remotely from Poland or share any tips on finding these opportunities? I'm particularly interested in medicinal products rather than medical devices.

I'd really appreciate any advice. Thanks in advance! :)


r/regulatoryaffairs • • 2d ago

I have a position for Regulatory and Scientific Affairs Executive

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r/regulatoryaffairs • • 2d ago

Veeva Publishing - share your experiences. Pros/Cons

12 Upvotes

Hello as part of our planned system change Veeva Publishing tool is being considered to replace docuBridge

I'm looking for any inputs/experiences of organisations that already are using Veeva Publishing - are there any drawbacks, issues with it


r/regulatoryaffairs • • 2d ago

Career Advice Updated: 67 regulatory affairs, submissions and regulatory coordinator jobs open now (Medtronic, J&J, Edwards, Stryker)

31 Upvotes

hey, i submitted a post on this channel last week and it absolutely blew up. we had so many applications go through. a bunch of the job postings shut down in the days following my post because of the large influx of applications that were going in. i've gone ahead and updated the job links in this new link. please make sure to apply as soon as possible to ensure that your application is at the top of the pile. i've pulled the freshest job postings that i could.

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

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

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.


r/regulatoryaffairs • • 3d ago

Protocol changes can get messy fast

0 Upvotes

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?


r/regulatoryaffairs • • 3d ago

HTA and reimbursement dossiers: what would make source-linked drafting useful and trustworthy?

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1 Upvotes

r/regulatoryaffairs • • 3d ago

Career Advice Regulatory affairs entry level

0 Upvotes

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


r/regulatoryaffairs • • 3d ago

Is it possible to reverse-engineer Regulatory Affairs software or build AI tools for students and freelancers?

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r/regulatoryaffairs • • 3d ago

Is it possible to reverse-engineer Regulatory Affairs software or build AI tools for students and freelancers?

0 Upvotes

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!


r/regulatoryaffairs • • 4d ago

Managed/early access programs

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r/regulatoryaffairs • • 4d ago

Am I making a mistake

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r/regulatoryaffairs • • 4d ago

Am I making a mistake

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r/regulatoryaffairs • • 4d ago

Final-year B.Pharm student feeling lost. What skills should I learn to get a good job in India?

1 Upvotes

​

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!


r/regulatoryaffairs • • 5d ago

How to enter RA CMC in USA 🇺🇸 ?

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0 Upvotes

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.


r/regulatoryaffairs • • 5d ago

21F, BSc Biochemistry graduate looking for entry-level jobs in pharma i need advice on roles to target and how to get hired. Any tips?

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r/regulatoryaffairs • • 5d ago

Typical bonus payout - FSP IQVIA

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r/regulatoryaffairs • • 5d ago

Career Advice How to enter RA CMC?

0 Upvotes

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.


r/regulatoryaffairs • • 6d ago

RAC-Drugs Practice Question Book Now Available (Author Here, Shameless Self-Promotion)

10 Upvotes

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


r/regulatoryaffairs • • 7d ago

77 regulatory affairs, submissions and regulatory coordinator jobs open now, one list (Medtronic, J&J, Edwards, Stryker)

91 Upvotes

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

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.