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Introduction to
Regulatory Affairs Course

Kick-start your regulatory affairs career in 40 days

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

As seen in:

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Kick-start your Regulatory Affairs Career in 40 Days
(no previous experience needed)

In 40 days, you will progress from having no regulatory affairs experience and knowledge to:

✅Gaining 40+ CPD hours of regulatory knowledge

✅1 month of regulatory affairs work experience

✅Multiple interviews

Next Full Course Starts on​

6th July

 

Only 13 spaces

The course is held part time over a month​

On-Demand Recordings with Live Support

Are you looking for an entry level regulatory affairs job but have no experience?

Are you applying for numerous regulatory affairs jobs but are getting no interviews?

Did you know that most entry level regulatory affairs jobs require regulatory affairs experience?

​​​

​But how do you gain work experience without your first chance?

We provide a one month regulatory affairs internship, with no previous experience needed, just the relevant degree.

Read on to learn more.

Got regulatory affairs experience already?

Excel in your career by gaining experience in European and United States clinical trial, marketing authorisation application and variation submissions. Read on to learn more.

Success Stories from Past Students

From postdoc researcher to regulatory affairs trainee. Liviana Mummolo was a postdoc researcher looking to break into the pharmaceutical industry. But she had no pharma or regulatory affairs experience and didn't know where to start. She embarked on this course , where she gained significant regulatory knowledge. Her CV was reviewed and she gained multiple interviews. After her mock interview, she received two job offers. She then received further advice on how to choose between offers. She is now working as a regulatory affairs trainee for a medical devices company.

From pharmacy dispenser to regulatory affairs manager. Ms. T.A. wanted a career change. She was a pharmacy dispenser with a Biomedical Science degree but was unfulfilled in her role. With a keen interest in pursuing a career in regulatory affairs, she embarked on the course. After her CV was reviewed, she gained multiple interviews and with the support of a mock interview, was offered a Regulatory Affairs Officer position for a Medical  Devices company. More recently, she has progressed to a Regulatory Affairs Manager position within the same company

From pharmaceutical science graduate to landing a job at GSK. Mr. H Malik was a recent pharmaceutical science graduate with only several months of laboratory experience. He had no previous pharmaceutical or regulatory affairs experience but wanted to break into the pharmaceutical industry. After his CV was reviewed, he received an entry level job offer from GSK as a Project Coordinator, which he accepted. Following this position, he moved into quality assurance, holding several positions, including as an QA executive.

From biochemistry undergraduate to receiving a GSK regulatory affairs placement offer. Ms. S.A. was a Biochemistry undergraduate and aspiring regulatory affairs professional. With limited work experience, she wanted to gain a regulatory affairs placement in a pharmaceutical company to improve her career options. ​However, regulatory affairs placements for undergraduates are highly competitive. To stand out from the crowd she undertook this regulatory training and her CV was reviewed. This enabled her to obtain a Regulatory Affairs placement offer from GSK.

'I am very happy of course to finally transition from academia to...medtech... and so I really really recommend this course' 

Liviana Mummolo

[Career Change]

Past role: Postdoc Researcher
Role obtained: Regulatory Affairs Trainee (Medical 
Devices)

(Scientific Postdoc Researcher)

‘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. Thank you’

Ms. T.A. [Career Change]

Past role: Pharmacy Dispenser
Role obtained: Regulatory Affairs Officer (Medical 
Devices), Regulatory Affairs Manager

(Biomedical Sciences Degree)

‘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!’

Mr. H Malik [Graduate]

 

Past role: Laboratory Scientist
Role obtained: Project Coordinator (GSK),
Quality Assurance Executive


(Pharmaceutical Science Degree)

‘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. I gained critical skills such as teamwork and effective communication’

Ms. S.A. [Undergraduate]

Past role: Student
Role obtained: Regulatory Affairs placement offer from GSK


(Biochemistry Degree)

Early Booking Sale
Book in May for £200 off
the Introduction to Regulatory Affairs Course

Use the promo code at checkout:

Use promo code: BookinMay or

BookinMay3 (3 instalments option)

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Do You Have Any Questions?

Speak to our expert about your career goals and any questions regarding the course.  

We look forward to hearing from you.

Or send us an email

Our Course Tutor has worked with:

Course Tutor Profile

Rabiea

Principal Regulatory Consultant and Director

I am a UK registered pharmacist with over ten years of regulatory affairs experience gained from working in the UK Regulatory Health Authority (MHRA) as an Agency Reviewer and several global 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 biologicals, vaccines, medical device combinations, consumer products (OTC), small molecule and generic medicinal products​.

​I

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

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

  • LinkedIn
Full Intro to Reg Course

Full Intro to Reg Course

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What is Regulatory Affairs?

A profession responsible for the licensing and compliance of medicines to government regulatory standards through submissions to agencies that demonstrate the quality, safety and efficacy of a medicine.

Regulatory affairs professionals are responsible for keeping up to date with legislation and guidelines, ensuring medicines comply with regulatory requirements, authoring and preparing regulatory submissions throughout the lifecycle of a medicine, creating regulatory strategies and managing projects.

Getting into Regulatory Affairs is Hard

We conducted a study to find out why

For an entry level regulatory affairs role, there were 400 applicants

  • 40 had regulatory affairs experience

  • 23 had a regulatory qualification / course

  • 116 had pharmaceutical industry experience

  • 221 didn't have regulatory or industry experience

Which applicants would you interview?

Where do you fit in this ranking?

What do you need to do to increase your chances?

Regulatory affairs experience

Entry level Regulatory Affairs Role Applicants

40

Regulatory affairs course

23

Pharmaceutical industry experience

116

No regulatory or pharmaceutical industry experience

​​​

Recruiters will only consider those with regulatory experience

221

Regulatory affairs work experience increases your chances of getting an entry level role

​ No regulatory affairs work experience

400 job applications
(0.25% success rate)

​ Regulatory affairs work experience

10 job applications (10% success rate)

  • Work from home multiple times a week

  • High salary

  • Great career progression

  • Generous benefits

  • High demand

  • Specialist role

  • Will keep you interested

  • Benefits patients worldwide

  • Flexible hours and part time work

  • Potential for international travel

  • Bonus and shares

 

Business-style clothing

United Kingdom

Associate - £50,000

Manager - £80,000

Director - £110,000

Executive - £150,000+

United States

Associate - $100,000

Manager - $140,000

Director - $250,000

Executive - $350,000

Europe

Associate - €60,000

Manager - €80,000

Director - €110,000

Executive - €200,000+

Switzerland

Associate - 100,000 CHF

Manager - 140,000 CHF

Director - 200,000 CHF

Executive - 250,000 CHF

Regulatory Affairs Salary (2025)
 

Introduction to Regulatory Affairs Course

Gain regulatory affairs knowledge, work experience

and job mentoring to land your dream role

Are you looking for an entry level role in regulatory affairs?

Gain work experience in regulatory affairs even if you are new to this field.

 

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 expand your regulatory affairs knowledge, then this course is for you.​

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

40+ CPD hours of lectures and learning

On-Demand Lecture Recordings & Live Tutor Support

Remote and part-time

to fit around your work or studies

Exclusive Community for each cohort

Expert tutor

with over 10 years of experience

Job search mentoring

Until you get a job

Expert CV review

(rated 9 out of 10 by past students)

Lifetime access

Course book provided

1 Month of Work Experience

(part-time)

Careers Hub 

Job search training videos and resources

Mock interview & interview preparation package

European, UK and United States Regulations covered

Real World Case Studies 

after every lecture

Industry recognised certificate

Start Your Regulatory Career 

Full Course Programme

Week 1

Week 1 Variations Work Assignment

Week 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

How to Plan your Learning?

Starting a course can be challenging. However, here is our recommendation

on how to plan your learning around your work/studies effectively.

For each week, structure your learning as follows:

Monday

Tuesday

Wednesday

Thursday

Friday

1 to 2 hours of lectures and case studies each weekday

Saturday

4 to 8 hours 

work 

assignment

Sunday

Rest

2025 Course Feedback Report

8/10 means 8 points out of 10, where 10 out of 10  (10/10) is highly satisfactory and 0 out of 10 (0/10) is unsatisfactory.

  • Overall Course Rating 4.6 stars out of 5 stars

  • Regulatory affairs knowledge increased from 3/10 to 8/10 after the course​

  • Likelihood of recommending the course was 8/10

  • Quality and content of course book rated 8/10

  • Knowledge of course tutor rated 9/10

  • Confidence of applying for entry level regulatory role increased from 4/10 to 8/10 after the course

  • Quality of lecture content rated 9/10

  • Quality of case studies rated 9/10

  • Quality of work assignments rated 9/10

  • Satisfaction with quality of CV review 9/10

Half Course

EU or US Course

Full Course

​Half Course

  • 11+ CPD Hours of Learning

  •  EU, UK and US Regulations

  • Certificate on Completion

  • Real World Case Studies

EU or US Course

  • 30+ CPD hours of learning

  • EU, UK OR US Regulations

  • Certificate on Completion

  • Real World Case Studies

  • Work Experience (2 weeks)

  • CV Review

  • Course Book

Full Course

  • 40+ CPD hours of Learning

  • EU, UK and US Regulations

  • Certificate on Completion

  • Real World Case Studies

  • Work Experience (4 weeks)

  • Work Experience Project **
         (1 month, part-time)

  • CV Review

  • Mock Interview

  • Job Search Support*

  • Careers Hub Access

  • Exclusive Professional 
    Community

  • Course Book

*In the country where you have long term right to work

** Subject to to availability. Contact contact@entrytoregulatory.com to confirm

Why Choose Us?

Feature
Entry to Regulatory
Others
Comprehensive lecture series
Expert teacher
Case studies
Certificate
Professional reference
Work experience
Job search mentoring & resources
40+ CPD hours of learning
Expert CV review
Mock interview
EU, US and UK Regulations
Exclusive Community
Remote and part-time
Recorded lectures with live support

Want to get free access to three lectures, a case study and work assignment?

Try the free course

Sample Lectures

What is Regulatory Affairs? Sample Video 1

What is Regulatory Affairs? Sample Video 1

Play Video
What is in a Marketing Authorisation Application? Sample Video 2

What is in a Marketing Authorisation Application? Sample Video 2

Play Video

View the Course Brochure to see the full Course Outline / Lecture Programme

FAQ

What are the course fees?

Please click here for the course fees

Is the course certified?

This course is an industry recognised qualification with the primary aim of providing you with in-depth regulatory affairs knowledge and experience to assist you in getting a regulatory affairs job.

What support will I receive after completing the course?

CV review, mock interview, job search mentoring until you get a job, exclusive community access and job search advice and resources.

How do I get additional questions answered?

Please click here for contact options.

Is this course relevant to countries other than UK, EU or US?

Yes. There are modules directly applicable to other countries, such as eCTD content. There are topics thar are indirectly applicable. These topics are still relevant as other countries align their regulations to the EU or US and submissions are made to the EU or US first and then updated slightly for other countries.

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