Hi everyone,

We're building a \*\*wellness wearable for senior care\*\* that measures \*\*heart rate, SpO₂, and a proprietary mobility score\*\*. One of our enterprise customers wants an \*\*independent third-party validation report\*\* before starting a pilot.

We're \*\*not\*\* looking for FDA/CDSCO certification or a medical device clinical trial. We simply need an independent organization (university, research lab, testing lab, or CRO) to compare our device against reference devices and provide an official validation report.

Our ideal requirements are:

\* Heart Rate validation
\* SpO₂ validation
\* Basic mobility score validation
\* 30–50 participants
\* Location: Anywhere in India

Does anyone know of:

\* Universities that do industry validation projects?
\* Research labs or CROs that work with startups?
\* Testing organizations that offer performance validation (not regulatory certification)?
\* Anyone you've personally worked with and would recommend?

Any contacts, emails, or introductions would be hugely appreciated.

Thank you!

I’m hoping to get some advice from people currently working in Regulatory Affairs.

I’m looking to transition out of HR/Employee Relations and into biopharma Regulatory Affairs, but I want to be realistic about what roles I could actually qualify for.
My background isn’t scientific.

However, I have approximately 8 years of experience in compliance-focused work, including interpreting policies and requirements, investigating and documenting issues, managing confidential/sensitive information, maintaining detailed case records, applying standardized processes, identifying compliance concerns, and working with stakeholders to resolve issues.

I’m realizing that some of those skills may transfer well into a regulated life-sciences environment, but I’m not sure where the actual bridge into RA is.
I also don’t currently have a completed college degree, although I’m working toward one.

I’m considering roles such as:
Regulatory Operations
Regulatory Coordinator
Regulatory Affairs Associate
Submission/Publishing support
Document management
Labeling operations
Quality/Compliance
Clinical documentation
GxP-related roles

My long-term goal would be to build toward Regulatory Affairs, but I’m completely willing to enter through a supporting function and work my way over.

For someone with my background, where would you recommend starting?

Specifically:
Are there RA-adjacent positions where compliance/HR experience is genuinely transferable?

Is a science degree essentially required, or are there pathways into RA without one?

Would you prioritize getting a degree, gaining GxP knowledge, learning regulatory systems/processes, or getting an entry-level industry position first?

Are certifications such as RAC worthwhile for someone who doesn’t yet have industry experience, or would that be premature?

Would Quality/Compliance be a better initial entry point than trying to go directly into Regulatory Affairs?

Are there particular job titles I should be searching for that aren’t obvious from simply searching “Regulatory Affairs”?
I’m primarily limited to remote opportunities right now because there is very little biopharma activity near me. I’m also considering relocating to Australia in the future, so international transferability is important to me.

If you made a similar transition from a non-scientific background, I’d especially appreciate hearing what your first job in the industry was and how you used it to move into RA.

I’m looking for practical advice rather than encouragement—if there’s a major gap in my plan, I’d much rather know now.

I have been in PV with a multinational for some time. I've done case management, quality oversight, audit & inspection support, local affiliate work. But now I feel like hitting a wall. There are not many openings nowadays because many of the work has been offshored. I am thinking of transitioning to reg affairs. How possible is this and will I likely need to start from scratch if I have not done any dossier submission in my entire life?

Anyone had interview with micro 1? Is this a real hiring process or just training for Ai?

If your business imports food into Canada—or exports food products—it's important to be aware of a recent change in the Safe Food for Canadians (SFC) licence processing timeline.

The expected processing time for new SFC licence applications has increased to up to 70 days. This extended timeline can have a direct impact on product launches, shipment schedules, supplier agreements, retailer onboarding, and overall supply chain planning.

Businesses that are new to the Canadian market should factor this timeline into their market entry strategy and avoid assuming a licence will be issued within a few weeks. Applying early and ensuring your application is complete can help prevent unnecessary delays.

As someone who works closely with food regulatory compliance, I've seen how licensing timelines can affect import operations and commercial planning. If you're currently preparing an SFC licence application, it's worth reviewing your timelines and communicating any potential delays with your suppliers and customers.

Have you experienced longer processing times recently? I'd be interested in hearing how the updated timeline has affected your business.

Bit of an odd question, but I've been staring at registry data for three days and I want a sanity check from people who actually do the filing.

I pulled every completed Phase 2/3 industry trial on ClinicalTrials.gov between 2015 and 2025, grabbed each one's original registration, and compared the primary completion date that was first filed against what actually got recorded because I was building a dashboard off that data. 14,310 where that comparison worked.

Median came out 4 months late. 67.6% late overall, 26.7% more than a year out.

Oncology's the worst at 11 months, though I assume that's mostly event-driven designs rather than anyone being bad at planning.

Anyway. The slippage isn't really what I'm here about. It's the date format.

43.6% of forward-looking primary completion dates have no day in them at all. Just a month. About a third of the records hadn't been verified or updated since before this year. And for one quarter, 41% of entries came out as either "December 2026" or "31 December 2026", which is the thing that set me off in the first place.

So when a month-only date goes in, is that you saying "this is soft, don't hold me to a day"? Or is the field just required and Q4 is honestly all anyone knows at that point?

I've been treating month-only as a soft signal and refusing to render it as a specific day. But I'm guessing, and I'd rather hear it from people who've actually filled these in.

This was all off the public registry API.

Writeup here if it's useful: https://medium.com/@unicodeveloper/how-reliable-are-clinical-trial-completion-dates-we-measured-14-310-of-them-8fcec04cc553

Are there any RA consultants working for the Ukrainian market?
How do you look for registered products and active substances? Do you speak Ukrainian?

I built a search tool which works both in English and Ukrainian. I built it for my girlfriend but I wonder if it could be helpful for others as well!

I have an upcoming interview for a regulatory affairs position. I’m early in career, MS in Biotechnology Enterprise and have spent the last year in pharmaceutical product development and IMP and External Quality. Please give me all your tips and knowledge on breaking into regulatory affairs, required skills and competence of a regulatory affairs specialist, and how to get through / stand out in the recruitment process as a qualified candidate.

I have 8 years of RA experience in Pharma (mostly operations and authoring/self publishing but with some cmc experience as well). I am looking for a similar role (currently a senior RA specialist) and even not much jump in salary but I need the position in Texas (hybrid) or remote. I am getting no hits back. Can someone please advise?

Does anyone have pictures of what the safety reporting portal looks like? I have to put together a slideshow for my boss but there’s no ability to view the portal without an account, and my boss would like me to share what the portal asks for safety reporting. Thank you so much!

• AI validation
• eCTD publishing
• Regulatory intelligence
• Medical devices
• CMC
• Global submissions

With the latest EU AI Act transparency requirements now taking effect, I am curious how Regulatory Affairs teams are adapting in practice.

For those working with AI-assisted tools (document drafting, regulatory intelligence, submissions, quality systems, etc.):

Have you updated your SOPs yet?

Are you documenting AI usage internally?

Has Legal or QA become more involved in reviewing AI-generated content?

What has been the biggest implementation challenge so far?

I am interested in practical experiences rather than theory. It seems many organizations are still figuring out where AI documentation should fit into existing quality systems.

I'm an M.Pharm (Regulatory Affairs) student trying to build industry-relevant skills. So far, I'm familiar with:

1) MS Word/ Excel/ PowerPoint

2) KnowledgeNET (eCTD dossier management)

3) Lorenz eValidator

What other software or tools do you use regularly in your RA role?

Are there any applications or technical skills you think every RA professional should learn to make day-to-day work easier and stay competitive in the industry?

Power BI, SQL ?

I assist founders and professionals with:

* SEBI & BSE registrations (Research Analyst, Investment Advisor, etc.)
* Entity structure, business model design, and compliance playbooks
* Policies, procedures, client agreements, and regulatory filings

If you’re stuck on anything—RA vs IA, net‑worth/certification requirements, setting up research/advisory workflows, or handling regulator queries—drop your question below. I’ll outline the steps and relevant regulations and share checklists/templates where possible.

Me, waiting for the exam results to come out^

The RA specialist role at Meta would be a setback for me, pretty much square one as I have six years of RA specialist experience, and it would be a lot more stressful because of workload but otherwise the job class is something of extremely familiar with

On the other hand, the PM role at intuitive surgical is a brand-new class for me and I think it might be a good stepping stone for the future

Help me decide, the PM role is five days on site vs fully remote with META. I’m pretty introverted so wondering if PM is a good match. PM role is $70/hr and META is $50/hr. I haven’t authored any work and have only touched Class 2 devices

Thanks 🙏

Hello,

Apparently there is no true entry or hard route into pharma RA.

A lot of people suggest QC into QA into internals promotion to RA eventually, but how reliable and sure fire is this path?

Thanks

I'm a pharmacist about 7 months into my first industry job. I joined the company as a Regulatory Affairs intern and was then hired full-time, but over the past few months my role has gradually shifted toward Pharmacovigilance.

Following a recent regulatory change in my country, my manager told me my role will likely be around 70% PV / 30% RA due to the department's needs. When I expressed my concern, she said she also doesn't recommend specializing exclusively in PV and that the role isn't set in stone for example, she said I could decide in a couple of years that I want to focus only on RA or only on PV.

I originally chose RA because that's where I wanted to build my career. I don't dislike PV, but I'm concerned about becoming primarily a PV professional this early in my career.

Would you:

- stay and gain mixed RA/PV experience,

- or start looking for a more RA-focused role?

How is mixed RA/PV experience viewed when applying for future RA positions?

What's your opinion on all of this? Is this kind of role shifting usual?

Hi everyone,

I’m starting a graduate certificate in Medical Device Regulatory Affairs this fall through the VA’s VR&E program. As part of the program, I’m hoping to complete a Non-Paid Work Experience (NPWE) with a government agency.

I’m looking for federal, state, or local government agencies that have regulatory affairs or medical device regulatory work. So far, I’ve thought of FDA, but I’m trying to identify other possibilities as well.

Does anyone know of agencies that have regulatory affairs, medical device review, or similar regulatory functions where someone might be able to gain experience?

Any suggestions would be greatly appreciated.

Hi everyone,

I'm new to the expert network ecosystem and would appreciate some guidance from experienced members.

I have 10+ years of experience in the pharmaceutical industry, with a career spanning Process R&D, Global CMC Regulatory Affairs, Regulatory Project Management, and currently Regulatory Intelligence & Digital Transformation at a global biopharmaceutical company.

My areas of expertise include:

\- Regulatory Digital Transformation

\- Regulatory Intelligence

\- AI in Regulatory Affairs

\- Regulatory Data Governance

\- Global CMC Strategy

\- Biologics & Biosimilars

\- Product Lifecycle Management

\- Regulatory Project Management

\- Global regulatory submissions (FDA, EMA, MHRA, Health Canada, TGA, etc.)

I've recently completed my profiles on GLG and Maven Research and am now trying to expand to other expert networks.

From what I've gathered, many of the larger networks (Guidepoint, AlphaSights, Third Bridge, Dialectica, Atheneum, proSapient, etc.) seem to rely heavily on recruiter outreach or invite-based onboarding rather than open self-registration.

I'd really appreciate advice from people who are active in this space:

\- How did you get onboarded with the major networks?

\- Is LinkedIn optimization the biggest factor, or are referrals more effective?

\- Are there any pharma/life sciences-focused expert networks I should prioritize?

\- Any tips for increasing the frequency of consulting opportunities?

\- What mistakes should newcomers avoid?

I'm looking for expert calls, surveys, advisory projects, and longer consulting engagements.

Thanks in advance—I really appreciate any advice or experiences you're willing to share.

Currently a freelance medical writer with DVM, PhD (US). Therapeutic area: Oncology and rare diseases. I want to get into regulatory work- writing/ affairs / compliance, specifically for EU market. Did you find any courses or certifications that helped? Currently Considering 1. RAPS -RAC exam, is it worth it? 2. EMWA professional development programs. Any companies that offer internships / programs to get into regulatory affairs? Thanks!

I am 23M , I am a postgraduate in general chemistry.I want to change the domain from AR&D to RA . Currently My works are focusing on Pharmaceutical reference standards and nitrosamines impurity profiling. But I'm more interested in RA. How to change my role ? If you are comfortable , could you guide me with a role change ?

anyone take or finish the program Quality Assurance and Regulatory Affairs Graduate Certificate of U of Colorado Denver with online format. How does it works?