Twenty Years in Big Pharma — And Still Couldn't Get Into Regulatory Affairs Without Training
- 2 days ago
- 14 min read
Part of the Entry to Regulatory Success Stories Series
Forhad had spent over two decades inside three of the most respected organisations in pharmaceutical science — GSK, Charles River Laboratories, and AstraZeneca. He was a Senior Scientist. He had a biochemistry degree and a Master's in Pharmaceutical Sciences. He understood drug molecules from hit identification all the way through to clinical candidate. And when he decided he wanted to move into regulatory affairs, the industry largely ignored him. This is the story of how he broke the record as the fastest person to secure a job from the Entry to Regulatory course — and why he ended up at the MHRA.
When Experience Isn't Enough: The Hidden Career Wall in Big Pharma
There is a specific frustration that only long-serving pharmaceutical scientists understand.
It is not the frustration of feeling unqualified. It is the frustration of knowing, after 10, 15, 20 years in the industry, that your career has quietly narrowed into a single corridor — and that the doors to other corridors are harder to open than they should be.
In big pharma, the functional silos are deep. A scientist who builds a career in early discovery — the stage of drug development concerned with identifying and optimising potential drug candidates — accumulates genuinely exceptional scientific knowledge. But that knowledge is concentrated: small molecule chemistry, target identification, lead optimisation, hit-to-lead progression. The molecule's journey after it reaches clinical candidate stage, the regulatory submissions, the marketing authorisation applications, the post-approval variations, the interactions with the MHRA and EMA — all of that sits behind a wall on the other side of the organisation.
Forhad had been watching that wall for three years.
He had attended internal talks at AstraZeneca. He had sat in workshops covering the drug development pipeline from end to end. He had watched colleagues move into clinical operations, regulatory, and medical affairs. And he had recognised something important: the skills he had built over two decades in discovery science were directly translatable to regulatory affairs. What he didn't have was the regulatory-specific knowledge that would let him prove it.
I was senior scientist there, and it felt like to move up again there was probably a push to become either in the managerial role or doing lots of projects as a principal scientist — and I was looking at other options where I could maybe start another type of career but still use my knowledge." — Forhad
This is the big pharma ceiling that nobody talks about plainly. It is not a glass ceiling of discrimination. It is a functional ceiling — the point at which, to advance further in the scientific track, you either become a manager of scientists (which requires different motivations and skills) or a highly specialised principal investigator (which requires narrowing further, not broadening). Neither path suited Forhad. Regulatory affairs did.
📣 Already inside pharma and wondering how to make the switch to regulatory? At Entry to Regulatory, we work with scientists at every stage — from complete career changers to industry veterans like Forhad who want to pivot into regulatory roles without spending years in another full qualification. 👉 Find out how we can help
Why Big Pharma Experience Alone Won't Get You Into Regulatory Affairs
This is the part of the story that surprises people — including Forhad.
Twenty years of pharmaceutical industry experience. Two degrees. Time at three major organisations including GSK and AstraZeneca. Hands-on involvement in the drug development process. And still: regulatory affairs roles were not materialising.
The reason is structural. And it matters for anyone who assumes that general pharma experience is sufficient currency for a regulatory affairs application.
Regulatory affairs is a specialist function. Hiring managers are not simply looking for pharmaceutical scientists — they are looking for pharmaceutical scientists who can demonstrate understanding of the specific frameworks, documents, and processes that regulatory professionals work with daily. These include:
- The Common Technical Document (CTD) — the globally standardised format for marketing authorisation submissions, divided into modules covering quality (Module 3 CMC), non-clinical (Module 4), and clinical (Module 5) data
- Regulatory authority interactions — how companies engage with the MHRA, EMA, FDA, and other agencies throughout the drug development and approval process
- Variations and post-approval changes — the process for making approved changes to an authorised medicine
- GMP compliance — how manufacturing standards are integrated into the regulatory submission process
- The clinical trial regulatory framework — Clinical Trial Authorisations (CTAs), Investigator's Brochures (IBs), and their relationship to the regulatory dossier
A scientist who has spent their career in early discovery will have deep understanding of the science that underpins these documents. What they will not have is fluency in the frameworks, formats, and regulatory language itself. That gap is what interviewers find — and what training closes.
Choosing Training: Why Forhad Ruled Out the Long-Course Options
When Forhad started researching his options, he encountered the same landscape that most people in this position do.
There are two well-known institutional bodies in the UK regulatory affairs training space: RAPS (the Regulatory Affairs Professionals Society) and TOPRA (the Organisation for Professionals in Regulatory Affairs). Both are respected names. Both offer learning pathways for regulatory professionals.
I did look at the ones that were known in this industry — RAPS, and also TOPRA — but they were like masters and long, long things, and I didn't really want to spend huge amounts of time doing them. I've got family and I couldn't really do a year into a Master's and then take another few months to start looking for jobs." — Forhad
This is a calculation that many experienced professionals get wrong — in the direction of over-investing time rather than under-investing. A RAPS certification programme or a TOPRA postgraduate course provides rigorous academic grounding in regulatory affairs. If you are building a long-term CPD strategy over many years, they are genuinely valuable. But if you are a senior industry scientist who wants to make a regulatory move within months — and who already has 20 years of pharma context to draw on — the proportionality is wrong.
What Forhad actually needed was not years of theory. He needed:
1. A structured overview of the regulatory landscape — specifically how the drug development process he already understood maps onto the regulatory frameworks he did not
2. Practical exposure to the documents and processes that regulatory roles involve
3. CV and interview support calibrated to regulatory applications
The Entry to Regulatory course delivered all three in a timeframe that worked alongside his existing commitments. And he moved fast.
What the Course Taught a 20-Year Pharma Veteran
This is one of the most revealing dimensions of Forhad's story. He came to the course as arguably the most experienced pharmaceutical professional of the four testimonials featured in this series. And yet the course gave him things he genuinely did not know.
"Things like the Common Technical Document, what goes in it, the modules — these are things that the course really taught me and I thought they were really valuable. Understanding where clinical trials start and how they interact with regulatory bodies, getting those early documents put together and understanding what goes in there." — Forhad
From his position in early discovery, Forhad had direct experience with Investigator's Brochures and elements that feed the clinical implication review. But the formal CTD structure — Module 1 (administrative), Module 2 (summaries), Module 3 (quality/CMC), Module 4 (non-clinical), Module 5 (clinical) — and how they are compiled, submitted, and assessed was new territory.
Specific areas the course added:
- CTD Module structure — understanding the architecture of a marketing authorisation application
- CMC (Chemistry, Manufacturing and Controls) — quality-related regulatory requirements beyond what early discovery typically touches
- Non-clinical regulatory data requirements — how pre-clinical data packages are framed for regulatory submission rather than internal scientific review
- Regulatory agency websites — where to find forms, guidance documents, and templates (this sounds basic, but it is genuinely a barrier for people making the transition)
- Post-approval variation process — how approved changes are managed through the regulatory system
- Manufacturing and GMP integration — how quality standards connect to the regulatory lifecycle of a product
Forhad also gained a short placement with a regulatory consultancy firm during the course — a small organisation with three team members. They reviewed his course material, were impressed, and supported him in applying for permanent roles while he was placed with them.
The MHRA Option: Why Government Regulatory Roles Are Hiding in Plain Sight
Here is the insight that changed Forhad's job search — and the most practically useful piece of intelligence in this entire blog.
After finishing the course and completing his placement, Forhad applied to a number of private sector regulatory roles. The summer job market was quiet. Private sector companies were absorbing the impact of increased National Insurance contributions and broader pharmaceutical industry uncertainty. Entry-level regulatory roles were scarce. The few interviews he had were short and didn't progress.
Then someone offered a different perspective: try the civil service.
Forhad had not previously considered MHRA and government regulatory roles as a primary target. Most people in pharmaceutical careers don't — they think of regulatory affairs as an industry function, not a government one. This is a significant and costly blind spot.
The MHRA as a career destination for pharmaceutical scientists is consistently underrated. Here is why it deserves serious consideration
1. MHRA roles value industry experience highly
The MHRA is the UK's regulator for medicines, medical devices, and clinical trials. Its scientific assessors, committee advisors, benefit-risk evaluators, and policy professionals work directly with the same regulatory documents, scientific dossiers, and product data that industry regulatory professionals produce. Industry experience is not just accepted — it is actively sought.
Associate Scientific Assessor roles at the MHRA have been advertised with starting salaries around £44,825, rising through grades. Senior and G6 roles can command significantly higher compensation. The regulatory knowledge is transferable in both directions: industry to regulator, and regulator to industry.
2. Government regulatory roles offer stability that private sector cannot match
The pharmaceutical industry is cyclical. Mergers, pipeline decisions, patent cliffs, and macroeconomic shifts create waves of hiring freezes and layoffs. Civil service roles, by contrast, are not subject to the same pressures.
Someone told me they work in civil service and they're going to be less affected by the National Insurance contribution because it's a government job — the private industry can be more affected by it, and they're going to be more likely to have layoffs." — Forhad
In a period of pharmaceutical industry contraction — which characterised much of 2024 and into 2025 — this stability is not a trivial advantage.
3. MHRA provides a unique regulatory perspective
Working at the MHRA means sitting on the assessment side of the regulatory process — reviewing submissions rather than preparing them. This perspective is immensely valuable for long-term regulatory careers. Professionals who have experience as both industry regulatory submitter and government regulatory assessor are highly sought after across the entire lifecycle of their career.
4. The MHRA route is genuinely accessible from a pharma science background
Forhad applied for multiple MHRA roles — Change Advisor, Committee Advisor, and one other. He was called for three interviews. He was placed on the reserve list for one role, which then converted to a formal offer. He accepted. He is now at the MHRA.
The record for fastest job placement from the Entry to Regulatory course. From Senior Scientist to Committee Advisor, MHRA.
The Interview Format Nobody Tells You About
One of the most specific and practically valuable pieces of insight from Forhad's experience concerns interview format — and it has direct implications for anyone targeting MHRA or other civil service roles.
Government interviews operate on a fundamentally different structure to private sector pharmaceutical interviews.
Civil service/MHRA interview format:
- Competency-based, structured questions prepared in advance
- Fixed question set — the panel goes around the board with the same questions for every candidate
- STAR-format answers expected (Situation, Task, Action, Result)
- The interview does not evolve in response to candidate answers
- There is no room for the conversation to develop in unexpected directions
Big pharma interview format:
- Often more conversational and flowing
- Interviewers follow threads of interest, leading candidates to expand in directions the panel finds compelling
- Scientific depth is probed through follow-up questions
- Personality and cultural fit assessed through more organic dialogue
These are not minor stylistic differences. They are fundamentally different assessment models. A scientist accustomed to big pharma interviews — where their scientific expertise and personality can carry a conversation to unexpected and impressive places — may find a civil service interview disorienting. The structured format requires precise, pre-prepared answers that directly address specific competency frameworks. There is no ability to compensate with charm, depth, or rapport.
The Entry to Regulatory mock interview specifically prepared Forhad for this.
"The format is very different [in government] — that was very useful. They've got questions and they're going to stick to those questions and they're going to go round the board with those questions. It's not like big pharma interviews where it can evolve when they have questions in mind, but they will let you talk and it will go in different directions depending on how interested they are." — Forhad
For anyone targeting MHRA roles specifically, this is not a nice-to-know. It is a performance-critical insight. Preparation in the big pharma interview style will not serve you well in a civil service panel. You need to know the competency frameworks, prepare structured answers, and deliver them precisely. The mock interview element of the course provided Forhad with exactly that preparation.
Forhad's assessment of RAPS and TOPRA — "masters and long long things" — reflects a practical reality for experienced professionals with family commitments. The question is not whether those programmes have merit in the abstract. It is whether they are the right tool for someone who needs to make a specific career transition in a specific timeframe without suspending other professional and personal commitments.
For Forhad, the Entry to Regulatory course provided the foundation, the practical exposure, and the application support he needed — and he moved faster than anyone on the course has managed before or since.
What This Means for Senior Scientists Considering the Regulatory Move
Forhad's story has direct and specific implications for any pharmaceutical scientist who recognises the ceiling he described.
You probably know more than you think — but not in the right format
If you have spent years in drug development, you have lived alongside the regulatory process. You may have contributed scientific data to IND applications or regulatory response letters. You may have attended R&D meetings where regulatory strategy was discussed. You have tacit knowledge of how regulatory decisions affect drug development timelines.
What you likely lack is the structural knowledge of how that regulatory process is formally organised — the CTD architecture, the submission pathways, the variation types, the authority workflow. That is learnable. It is not a fundamental gap; it is a translation problem.
Your pharma background is a genuine asset — especially at MHRA
Regulatory authorities value industry experience because it means candidates understand the perspective of the organisations they will be reviewing. A scientist who has spent time in early discovery and knows how CTD Module 4 (non-clinical) data is generated from the inside is a more effective evaluator of that section than someone who has only ever seen it from the assessor's desk.
Forhad's background at GSK, Charles River, and AstraZeneca was not irrelevant to his MHRA application. It was an asset.
The hidden job market is particularly relevant for experienced candidates
One of Forhad's specific observations is worth highlighting as standalone career advice:
"Someone in early discovery that wants to move into regulatory — just do a course like this, get it down on paper that you've made the effort to learn about regulatory, and then you can use that knowledge to start applying for regulatory roles." — Forhad
And separately, on job searching strategy: the most visible job listings — those on major platforms like LinkedIn — are often the most competitive. Smaller companies, medical device firms, and government bodies advertise less prominently and face lower application volumes. For candidates in career transition, this is where the realistic opportunities frequently sit.
Frequently Asked Questions
I have a background in drug discovery. Is that useful for regulatory affairs?
Absolutely — though perhaps not in the way you expect. Drug discovery scientists have direct experience with the scientific data that forms the core of regulatory submissions: characterisation data, pharmacological studies, ADMET profiles, toxicology. The gap is not scientific depth — it is regulatory framework knowledge. Knowing the CTD structure and how your existing knowledge maps onto it is what structured training provides.
Is the MHRA a realistic target for someone transitioning from industry?
Yes. MHRA actively recruits scientists with industry backgrounds. Associate Scientific Assessor, Committee Advisor, Change Advisor, and Benefit Risk Evaluation Assessor roles have all been filled by industry scientists making this transition. MHRA values the perspective of professionals who understand how submissions are prepared from the inside.
Is a civil service career a step down from big pharma?
Not at all. MHRA roles offer competitive salaries, pension benefits, job security, and the unique opportunity to work across the full breadth of the medicines landscape rather than a single company's portfolio. Many regulatory professionals view a period at a regulatory authority as a career accelerator that significantly enhances their market value when they return to industry.
How does the civil service interview differ from pharma, and how should I prepare?
Civil service interviews use a structured competency framework (often linked to the Civil Service Behaviours framework). Questions are fixed, delivered in a set order, and assessed against predetermined criteria. Answers should be prepared in STAR format (Situation, Task, Action, Result) and delivered clearly and concisely. There is no room for conversational evolution. Preparation is more explicit and structured than for most pharma interviews.
How long did Forhad's journey take?
Forhad holds the record as the fastest person to secure a job from the Entry to Regulatory course. He enrolled in spring, completed the training, conducted his job search during a challenging summer market, and accepted an offer at MHRA. The total timeline from course start to job offer was faster than any previous student on the programme.
The Ceiling Isn't the End of the Road
If you have spent years building expertise in pharmaceutical science and you are looking at the career options ahead of you — more management, more specialisation, or something entirely different that still uses what you know — regulatory affairs is not a compromise. It is a redirection.
Forhad's twenty years at GSK, Charles River, and AstraZeneca did not become irrelevant when he joined the MHRA. They became his strongest qualification. The knowledge he had — of how molecules are made, characterised, studied, and developed — is exactly what a regulatory authority needs when it evaluates the submissions companies put in front of it. He didn't leave the pharmaceutical industry. He moved to its centre.
"If you want to make the switch, doing a course like this would really help. Anyone in early discovery that wants to move from there into regulatory — just do a course like this, learn about it, get it down on paper that you've made the effort, and it will make a difference." — Forhad, Senior Scientist (GSK / Charles River / AstraZeneca) → Committee Advisor, MHRA
At Entry to Regulatory, we work with pharmaceutical scientists at all stages — including experienced professionals who are ready to use everything they know in a new direction.
We offer:
- 🔬 Regulatory knowledge training built for scientists who already understand the industry — you won't be taught things you know, but you will learn the frameworks you don't
- 📄 CV review — we know exactly how to present a drug discovery background for regulatory roles, in both private sector and civil service formats
- 🎤 Mock interviews calibrated for both private sector and civil service formats — including the structured competency-based approach that MHRA and government regulatory roles require
- 💼 Real-life work assignments including CTD compilation, to give you practical examples you can discuss with confidence in any interview
- ✅ Flexible, part-time delivery designed to be completed alongside existing work commitments
If you are a pharmaceutical scientist who has spent years in the lab and is ready for your regulatory chapter, the fastest route in is a conversation with us.
Talk to us. Forhad did — and he's at the MHRA.
Next cohort starts: 12th July 2026. Limited spaces available.
About the Author: Rabiea is an Honorary Associate Professor at UCL, former MHRA Health Authority reviewer, and CEO of Entry to Regulatory and Advanced Regulatory Consulting. After transitioning from retail pharmacy to regulatory affairs, she has dedicated her career to helping others make the same successful career change. Connect with her on LinkedIn for the latest regulatory affairs insights and career advice.
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