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Pharmaceutical laboratory setting for online regulatory affairs training course and certification
Rated 4.3/5 by past students
Trained over 1698 students across 22 countries

Kick-Start Your Regulatory Affairs Career in 90 Days with a Regulatory Affairs Course, Certification and Internship
(No previous experience needed)

Regulatory affairs certification that provides you with regulatory affairs work experience, knowledge and job search mentoring until you land your dream job in Reg. Affairs

Online, remote and part-time regulatory affairs training to fit around your work and studies. All you need is a life science, chemistry, pharmacy or healthcare degree. Try Free Regulatory Affairs Course.

Includes 3 Months Real Work Experience
50+ CPD Hours of Learning 3 Months Regulatory Affairs Internship Job Search Mentoring Until HiredOnline, Remote & Part-Time Pay in InstalmentsFree Regulatory Affairs Course Sample

Kick-start your Regulatory Affairs
Career in 3 Months

(no previous experience needed)

In 3 months, you will progress from having
no regulatory affairs experience and knowledge to:

Gaining 50+ CPD hours of EU, US and UK regulatory knowledge
3 months of regulatory affairs work experience
Job Search Mentoring until you find a job
Multiple interviews
Past students have gained a regulatory affairs job on average, 2 weeks to 6 months from starting the course*

Next Full Course Starts on:

14 September 2026

(previous cohort sold out)

⏳ Registration closes in:

--Days : --Hours : --Mins : --Secs

Limited Spaces

The course is held part time over 3 months (6 hours per week)

It is remote and online so you can take part from anywhere in the world

On-Demand Recordings with Live Support

Start my Regulatory Career Book a call

What Our Regulatory Affairs Courses Include

Comprehensive Regulatory Affairs Course

Gain regulatory affairs knowledge, work experience and job mentoring to land your dream role

Do you want to progress in your regulatory affairs career? Or move into regulatory affairs?

If you are interested in becoming a regulatory affairs professional but have no experience, or if you are working in regulatory affairs but would like to progress in your career

Then this course is for you.

Gain work experience in regulatory affairs without previous experience. Just a life science, healthcare, pharmacy or chemistry degree

This is the most comprehensive regulatory affairs introductory course available, which includes:

50+ CPD Hours of Learning

Comprehensive lectures covering EU, UK and US regulations, clinical trials, marketing authorisations, variations and post-approval submissions.

3 Months Work Experience

Gain hands-on regulatory affairs work experience through real-world case studies and regulatory submission assignments.

Job Search Mentoring

Receive expert support until you get a job — including CV review (rated 9/10), mock interviews, and career strategy guidance.

Industry Recognised Certificate

Receive a certificate recognised by the MHRA, GSK, and other major pharma companies, medical device firms, and regulatory consultancies.

On-Demand Recordings

Recorded lectures with live tutor support. Study at your own pace with flexible scheduling — only 6 hours per week.

Expert Tutor

Learn from an Honorary Associate Professor at UCL, former MHRA Agency Reviewer with 10+ years of regulatory experience at GSK, MSD, and Bayer.

Course Format

3 Months
Part-time, online, remote course
6 hrs/week
Fits around your work and studies
50+ hours of learning
Lectures, case studies and work assignments
Live Support
Direct expert tutor interaction
Careers Hub — job search training videos and resources
Exclusive professional community for each cohort
Real world case studies after every lecture
3 months online access
Expert CV review (rated 9/10 by past students)
Mock interview preparation
Job search mentoring until you get a job

As seen in:

Royal Society of Chemistry
UCL
TOPRA
C+D
JPAG — Joint Pharmaceutical Analysis Group

Full Course Programme

(part-time online course)

Module 1

Module 1 Variations Work Assignment

Module 1 Lectures and Case Studies

Welcome and Course Overview

  • What is regulatory affairs?
  • What is this course about?
  • Course benefits, feedback, tutor experience
  • What will you learn (detailed)
  • What experience and skills will you gain?
  • What Job Support will you get?
  • Learning portal

Drug Development and What is Regulatory Affairs?

  • Medicine types, regulation and history
  • Drug development process
  • The regulatory affairs role
  • The regulatory framework
  • Regulatory authority responsibilities and procedures

What is the Role of the Regulatory Affairs Professional?

  • The regulatory environment
  • The role of the regulatory affairs professional
  • Career progression, salary and benefits
  • The skills and responsibilities needed
  • Regulatory work that you will be involved in
  • Real regulatory submission examples

Background of Medicines Legislation — US, EU, UK

  • The global regulatory environment
  • The role and structure of the FDA, EMA and MHRA
  • The standards, legislation and guidance for the US, EU and UK
  • The laws underpinning US, EU and UK medicines regulation
  • Regulatory hot topics

EU and UK Regulatory Procedures Part 1

  • The EU and UK regulatory environment
  • The phases of a clinical trial
  • EU & UK clinical trial procedure and timelines
  • EU Marketing Authorisation Application procedure and timelines
  • EMA scientific committees

EU and UK Regulatory Procedures Part 2

  • The centralised procedure
  • The decentralised procedure
  • The mutual recognition procedure
  • The UK marketing authorisation application procedures
  • EU and UK variation procedures

Who Is This Regulatory Affairs Course For?

Whether you're a recent graduate, undergraduate student, or an experienced professional looking to transition, our course is designed for you

Pharmacy & Healthcare Professionals

Pharmacists, hospital pharmacists and healthcare professionals — transition into the high-demand regulatory affairs sector. Many of our successful students came from pharmacy backgrounds.

Life Science Graduates & Undergraduate Students

Any life science or healthcare degree holder or current undergraduate student can join. No previous regulatory or pharma experience needed to get started.

QC/QA/CMC Specialists

Leverage your quality and manufacturing knowledge to move into regulatory affairs roles with higher salaries and career progression.

Clinical Research Professionals

Expand your clinical trial knowledge into the full regulatory lifecycle — from CTAs through to marketing authorisations.

Pharma & Regulatory Professionals

Pharmaceutical industry professionals and regulatory professionals looking to fill knowledge gaps, upskill or gain a recognised qualification to boost their career.

Academic Researchers & Career Changers

Move from academia to industry. Like Liviana, who went from postdoc research to a regulatory affairs trainee role in medical devices. Remote and flexible learning fits around your work or studies.

Regulatory affairs career growth, salary progression and job opportunities by country

Regulatory Affairs Salary by Country

Regulatory affairs is one of the highest-paid specialisms in the pharmaceutical and medical devices industry

United Kingdom flag

United Kingdom

Associate£50,000
Manager£80,000
Director£110,000
Executive£150,000+
United States flag

United States

Associate$100,000
Manager$140,000
Director$250,000
Executive$350,000
Europe flag

Europe

Associate60,000
Manager80,000
Director110,000
Executive200,000+
Switzerland flag

Switzerland

AssociateCHF 100,000
ManagerCHF 140,000
DirectorCHF 200,000
ExecutiveCHF 250,000

* Figures based on a Michael Page salary survey

▪ Work from home▪ High Salary▪ High Demand▪ High Job Stability▪ Great Career Progression▪ Interesting▪ Help Patients Globally▪ Specialist role

How to Get a Regulatory Affairs Job Without Experience

Getting into regulatory affairs is hard. Our study found that for a typical entry-level regulatory affairs role, there were 400 applicants — but only 40 had regulatory affairs experience.

0.25%
Success rate without regulatory experience (400 applications)
10%
Success rate with regulatory experience (10 applications)

Our course bridges this gap by giving you 3 months of real regulatory affairs work experience, making you stand out from hundreds of other applicants.

Start Building Experience (opens in new tab)

Entry Level Regulatory Affairs Role Applicants

Regulatory affairs experience
40
Regulatory affairs course
23
Pharmaceutical industry experience
116
No regulatory or pharmaceutical industry experience
221

Recruiters will only consider those with regulatory experience

Where do you fit in this pyramid?

What step can you take today to move up the pyramid and improve your job profile?

Past students have gained a regulatory affairs job on average, 2 weeks to 9 months from starting the course.*

(Average 4 months)

Case Studies & Testimonials

Hear from past students who successfully transitioned into regulatory affairs careers

Jas

Career Change Pharmacy MSc
"Gained a job offer from MHRA 4 months from starting the course. I really recommend this course."

Hospital pharmacist who wanted to transition into regulatory affairs. After completing the course, she secured a position at the MHRA within 4 months.

Previous Role Hospital Pharmacist
Role Obtained MHRA

Liviana Mummolo

Career Change Post-Doc, Chemistry
"I am very happy of course to finally transition from academia to...medtech... and so I really really recommend this course."

From postdoc researcher to regulatory affairs trainee. She had no pharma or regulatory experience. After the course she received two job offers and moved into medical devices

Previous Role Postdoc Researcher
Role Obtained Regulatory Affairs Trainee
Salary 90,000 CHF

Prabhjot

Career Change Pharmacology MSc
"I thought I knew about regulatory affairs — but I knew nothing. This course gave me so much knowledge, insight and experience that I landed 4–5 regulatory interviews and accepted a Senior RA position at Amgen. Without this course, I would not have been able to get this job. It is worth every penny."

QC Senior Scientist (Pharmacology MSc) who landed 4–5 regulatory interviews and secured a Senior Regulatory Affairs Associate role at Amgen within 4 months.

Previous Role Quality Control
Role Obtained Senior RA Associate (Biotech)

Forhad

Career Change Pharmaceutical Science BSc
"After finishing the course, I had a lot of knowledge that I didn't have before. I got called for 3 interviews and was offered 2 jobs. I chose the role with the MHRA."

Senior Research Scientist who transitioned to regulatory affairs at the MHRA within 4 months of starting the course. Received multiple job offers.

Previous Role Senior Research Scientist
Role Obtained MHRA Regulatory Affairs

Adebukola

Career Change Pharmacy MSc
"This course gave me a deep dive understanding of UK and EU regulations — and that self-confidence shone through in my interviews. The case studies were excellent: real-world scenarios that made everything tangible."

Senior Project Manager in consumer healthcare (Pharmacy MSc) who transitioned to Regulatory Executive at Wockhardt — one of the UK's largest generic pharmaceutical companies — within 4 months of completing the course.

Previous Role Project Manager
Role Obtained Regulatory Executive, Wockhardt

Ms. T.A.

Career Change
"I can't recommend this enough. It is more than just a service; it is life changing. I had many interviews and got my first regulatory affairs job with a medical devices company."

She was a pharmacy dispenser with a Biomedical Science degree. After the course and CV review, she gained multiple interviews and was offered a Regulatory Affairs Officer position. She has since progressed to Regulatory Affairs Manager.

Previous Role Pharmacy Dispenser
Role Obtained Regulatory Affairs Manager

Mr. H Malik

Graduate
"This is truly exceptional when it came to obtaining a specific job I was pursuing. By the end, I was able to receive multiple job offers. I secured a job with GlaxoSmithKline!"

A recent pharmaceutical science graduate with only several months of lab experience. After CV review, he received an entry level job offer from GSK and later progressed into quality assurance.

Previous Role Laboratory Scientist
Role Obtained Project Coordinator (GSK)

Ms. S.A.

Undergraduate
"I've gained a strong foundation in regulatory affairs, such as CTD structure, MAA change controls, variations and CMC, as well as undertaking work experience."

A Biochemistry undergraduate who wanted to gain a regulatory affairs placement. Regulatory placements for undergraduates are highly competitive — this training helped her stand out and secure a placement at GSK.

Previous Role Student
Role Obtained Regulatory Affairs Placement at GSK

Meet Your Course Tutor

Rabiea — Regulatory Affairs Course Tutor, Honorary Associate Professor at UCL, Former MHRA Agency Reviewer
Linkedin
Rabiea LinkedIn profile photoRabiea 🔷️ Assoc. Professor

CEO 🔷 Regulatory Affairs Courses 🔷 Ex. MHRA CMC Assessor 🔷 Regulatory Affairs Consultancy 🔷 Honorary Associate Professor (UCL) 🔷 Contact for Regulatory Consulting Support or Training 🔷 Advance Regulatory Consulting

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Rabiea

Associate Professor (Hon), UCLFormer MHRA Agency ReviewerCEO Advance Regulatory Consulting, CEO Entry to Regulatory

I am an Honorary Associate Professor at UCL, a former MHRA Agency Reviewer and CEO of Advance Regulatory Consulting (regulatory affairs consultancy) and Entry to Regulatory (regulatory affairs training company).

I have over a decade of regulatory affairs experience gained from working for the UK Regulatory Health Authority (MHRA) as an Agency Reviewer and several large pharmaceutical companies, such as, GSK, MSD and Bayer.

My experience covers the entire product lifecycle, from clinical trial applications through to new drug applications and post-approval changes. I have worked on various medicinal products, including cell and gene therapeutics, biologicals, vaccines, medical device combinations, consumer products (OTC), small molecule and generic medicinal products.

I have successfully delivered multimillion-dollar regulatory approvals and cost savings repeatedly for numerous pharmaceutical companies throughout the EU, US, UK, and rest of world markets.

I am passionate about regulatory affairs and providing exceptional regulatory support for pharmaceutical and biotechnology companies to accelerate innovation and deliver for patients. Furthermore, I am passionate about training other regulatory affairs professionals and growing the profession.

Direct Interaction with Associate Professor Tutor

Unlike other courses, you get direct one-on-one interaction with Rabiea through messaging and live meetings. She brings her real-world MHRA and pharma experience directly to your career guidance.

Rabiea has trained health authorities across the globe, such as SFDA, DRAP, and others.

Our course graduates have started careers with:

Amgen
Lonza
MHRA — Medicines and Healthcare products Regulatory Agency
Wockhardt
GSK
Takeda
NIHR — National Institute for Health Research
Werfen
Kenvue
mylife Diabetescare
Catalent
Accellerate
Alliance
DLRC
Course Brochure

Browse the Full Course Details

Flick through our course brochure to see the full curriculum, work experience modules, career support and everything included in your enrolment.

Can’t see the brochure? Open in a new tab ↗

Download PDF

Course Options & Pricing

Choose the package that fits your career goals. Pay with instalments, Klarna, or PayPal.

MOST POPULAR

Full Course

3 months Regulatory work experience, 50+ hours of learning and careers support until you get a job

No previous experience needed. Students from across the world. Life science, chemistry, pharmacy or healthcare qualification needed.

Part-time, remote and online training that runs over 3 months. 6-hours per week. Flexible study.

  • 3 Months Regulatory Affairs Work Experience / internship (with work reference)
  • 50+ CPD hours of Regulatory Lectures and Assignment (including MAA, NDA, BLA, CTA, CTIMP, IMPD, IND, post-approval changes )
  • Careers Support Training and Resources – Full training, templates, and resources covering A to Z of your job search
  • Expert Professor and ex-MHRA Tutor - Live support and Q and A sessions with expert
  • Job Search Mentoring until you get a job – 1-1 mentoring, Live careers support**
  • Industry Recognised Certificate
  • Real World Case Studies
  • 1 x Expert CV Review
  • 1 x Mock Interview
  • Exclusive Regulatory Community
  • Additional Work Experience Project (additional charge)
  • 3 months online access - upgrade to lifetime Access available*
  • European, United Kingdom and United States Regulations Covered

*Lifetime access to course book (additional charge)

**In the country where you have long-term right to work (where you have a valid sponsorship/visa already)

View Prices (opens in new tab)Sign Up (opens in new tab)

Core Course

50+ hours lectures + 3 months Regulatory work experience

  • 50+ CPD Hours of Learning
  • EU, UK, US Regulations
  • Expert ex-MHRA Tutor
  • Industry Recognised Certificate
  • Real World Case Studies
  • 3 Months Work Experience (part-time)
  • 3 months online access
View Prices (opens in new tab)Sign Up (opens in new tab)

Free Regulatory Affairs Course (Sample)

Try before you commit — no cost

  • 3 hours of regulatory affairs training
  • Lectures – CTD, MAA, variations, regulatory strategy, FDA, EMA
  • Work experience assignment – Module 1
  • Case Study – Variations
  • How to move into regulatory affairs – full blueprint
  • No Payment Required
  • Instant Access
Sign Up (opens in new tab)

Flexible payment options: Instalments • Klarna • PayPal

Not sure which option is right for you?

📅 Book a Free Intro Call

What Happens After You Enrol

Your step-by-step journey from enrolment to a regulatory affairs job

1Enrol
2Registration Forms
3Join Cohort Group
4Receive Course Book
5Welcome Call
6Course Lectures
7Course Work Experience
8Careers Support & Job Search Mentoring
9Regulatory Job

Your Month-by-Month Timeline

Monthly course timeline
PeriodActivity
Month 1Week 1 Introductory Lectures and case studies
Week 2 Europe Lectures and case studies
Week 3 US Lectures and case studies
Week 4 Advanced Lectures and case studies
Month 2CV Review, [Apply for Jobs]
Work Assignment 1 – Variations/Post-approval
Work Assignment 2 – Regulatory Strategy
Month 3Work Assignment 3 – MAA/NDA
Work Assignment 4 – Clinical – IMPD/IND
Apply for Jobs
Month 4+
Until you get a job
Careers Hub, Apply for Jobs
Job Search Mentoring, Mock Interview
Additional Work
Experience
Get an additional 2 to 12 months of regulatory work experience covering more regulatory submissions (additional charge applies)

How to Plan Your Learning

This course has been designed to fit around your work and studies so you don’t need any time off and you can upskill yourself while working.

You only need to spend 6 hours per week (part-time). That can be any time of day or any days of the week.

Here is an example of how to plan your learning

  • 1 hour per day Mon to Sat OR
  • 1.5 hours on Mon, Tue, Wed, Thu OR
  • 2 hours on Fri, Sat, Sun OR
  • 3 Hours on Sat and Sun

Why Choose Entry to Regulatory?

See how we compare to other regulatory affairs courses

Comparison of Entry to Regulatory course features versus other regulatory affairs courses
FeatureEntry to RegulatoryOthers
Comprehensive Lecture Series
Expert Teacher (Assoc. Prof. CEO, former MHRA)
Case Studies
Certificate and Professional Reference
3 Months of Work Experience
Job Search Mentoring and Resources
50+ CPD hours of learning
Expert CV Review
Mock Interview
European, UK and United States (or Global) Regulations
Exclusive Professional Community
Online Recorded Course with Live Support and ad-hoc Q and A sessions

Course Ratings

4.30
Average Rating
Level 5
46%
Level 4
39%
Level 3
14%
Level 2
1%
Level 1
0%

Key Performance Metrics

Course Tutor Knowledge90%
Lecture Quality87%
Case Studies85%
Course Book Content85%
Applicability to Role84%
Recommendation Score83%
Work Assignments83%

Regulatory Affairs Courses Available Worldwide

Our online regulatory affairs training is accessible from every country. The course is remote and online, so you can participate from anywhere in the world.

Regulatory affairs courses available in all countries including United Kingdom, United States, Germany, France, India, Canada, Australia, Switzerland, Japan, China, Singapore, South Korea, Brazil, Saudi Arabia, United Arab Emirates, South Africa, Nigeria, Pakistan, Malaysia, and over 170 more countries worldwide.

Frequently Asked Questions

Everything you need to know about our regulatory affairs courses

Still have questions?

Book a free 15-minute intro call — we'll answer everything personally.

📅 Book a Free Intro Call
Career Guide

How to Get a Job in Regulatory Affairs

A step-by-step guide for graduates and career changers who want to break into regulatory affairs — even without prior industry experience

Regulatory affairs is one of the fastest-growing career paths in the pharmaceutical and medical device industries. Professionals in this field ensure that medicines, biologics, and medical devices comply with the regulations set by agencies such as the MHRA (UK), EMA (EU), and FDA (US). The demand for qualified regulatory affairs professionals continues to outstrip supply, which means salaries are competitive and job security is strong.

This guide explains exactly how to get a job in regulatory affairs, whether you are a recent life-science graduate, a pharmacist looking for a career change, or a QC/QA specialist wanting to move into a higher-paying role.

Understand What Regulatory Affairs Professionals Actually Do

Before pursuing a regulatory affairs career, it is important to understand the day-to-day work. Regulatory affairs professionals are responsible for preparing, submitting, and maintaining the documentation required to bring pharmaceutical products and medical devices to market. Their core tasks include writing Clinical Trial Applications (CTAs), compiling Marketing Authorisation Applications (MAAs), managing post-approval variations, and liaising with regulatory authorities.

They also advise internal teams on labelling, advertising compliance, and regulatory strategy across different markets. The work is detail-oriented, intellectually stimulating, and directly impacts patient safety — which is why regulators and employers place such a high value on properly trained professionals.

Get the Right Qualifications

Most regulatory affairs roles require at least a life-science or healthcare degree — such as pharmacy, biochemistry, biomedical sciences, or a related discipline. However, a degree alone is rarely enough to land an entry-level position. Employers expect candidates to demonstrate a working knowledge of EU, UK, and US pharmaceutical regulations, including the Common Technical Document (CTD) format, Good Manufacturing Practice (GMP), and the regulatory submission lifecycle.

Entry to Regulatory’s dedicated regulatory affairs training course bridges this gap. It is a course that include CPD-accredited learning, real-world case studies, and hands-on submission experience, which is particularly valued by hiring managers because it shows that you can contribute from day one.

Gain Practical Work Experience

The single biggest barrier to getting a regulatory affairs job is the “experience gap.” Most job adverts ask for at least one to two years of experience, which creates a catch-22 for newcomers. The most effective way to overcome this is to gain structured work experience as from Entry to Regulatory's training — for example, working on simulated or real regulatory submissions such as IMPDs, MAAs, and variation applications.

This type of practical experience gives you tangible examples to discuss at interview and demonstrates to employers that you understand the submission process end-to-end.

Tailor Your CV for Regulatory Affairs Roles

A generic CV will not get you shortlisted. Regulatory affairs hiring managers look for specific keywords and competencies: knowledge of ICH guidelines, experience with eCTD submissions, familiarity with GxP frameworks, and an understanding of the product lifecycle.

Having your CV reviewed by our industry expert, Rabiea can make a significant difference. Many successful career changers credit a professional CV review as the turning point that led to interview invitations.

Prepare for Regulatory Affairs Interviews

Regulatory affairs interviews typically combine competency-based questions with technical scenarios. You may be asked to explain the difference between a Type IA, Type IB, and Type II variation, or to walk the interviewer through the structure of a CTD Module 3 (Quality).

Practising mock interviews with our industry expert Rabiea who has real regulatory experience is invaluable. It builds confidence, helps you articulate your knowledge clearly, and prepares you for the specific style of questioning.

Target the Right Employers and Job Boards

Regulatory affairs roles exist across a wide range of organisations: global pharmaceutical companies (such as GSK, AstraZeneca, Roche, and Pfizer), medical device manufacturers, CROs, regulatory consultancies, and even government agencies like the MHRA and FDA. Entry-level titles to search for include Regulatory Affairs Associate, Regulatory Affairs Officer, Regulatory Affairs Coordinator, and Regulatory Affairs Trainee.

Specialist job boards and LinkedIn are excellent resources.

Consider Salary Expectations and Career Progression

In the UK, entry-level regulatory affairs salaries typically start at £30,000–£45,000, rising to £50,000–£80,000 at the associate and senior levels. Managers and directors can earn £80,000–£120,000, while VP-level and executive positions command £120,000–£150,000+. In the US, starting salaries are higher, with associates earning around $80,000–$110,000 and directors earning $180,000–$250,000+.

Career progression is typically faster than in many other life-science roles because regulatory expertise is highly specialised and in constant demand.

Summary: Your Regulatory Affairs Career Action Plan

  1. Step 1: Ensure you hold a life-science or healthcare degree.
  2. Step 2: Complete the Entry to Regulatory Comprehensive Regulatory Affairs Course that covers EU, UK, and US regulations.
  3. Step 3: Gain practical work experience through regulatory submission projects and case studies.
  4. Step 4: Have your CV professionally reviewed and tailored for regulatory affairs roles.
  5. Step 5: Practise mock interviews focusing on technical regulatory questions.
  6. Step 6: Apply to pharmaceutical companies, medical device firms, CROs, and regulatory consultancies.
Limited Spaces — Registration Closing Soon

Ready to Start Your Regulatory Affairs Career?

Spaces are limited, so we recommend signing up early. Try our free course sample first.

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