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Introduction to Regulatory Affairs Course

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If you are interested in becoming a regulatory affairs professional but have no experience, or if you are working as a regulatory affairs professional but would like to have a strong foundation on the basics of regulatory affairs, then this course is suitable for you.​

This is the most comprehensive regulatory affairs course available, providing you with a strong foundation in regulatory affairs by increasing your baseline knowledge, as well as offering you the hard to get real world work experience to enhance your skills and support to secure a career in regulatory affairs.  

Not only will you benefit from the comprehensive lecture series, but you will also obtain real world experience through case studies and work experience assignments. Furthermore, you will receive support in CV/Resume writing and interview practice to ensure you land your first regulatory affairs role. 

This course is run by our experts who have considerable experience in pharmaceutical companies and regulatory health authorities.

Why not have a look at the sample material below to see what to expect.

We will be offering the first couple of lectures and case studies for FREE, so enquire now to take advantage of this offer and get updates on this course:

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  • Live online classes 

  • Comprehensive series of lectures 

  • Expert course teachers

  • EU and US regulations covered

  • Work experience assignments

  • Real world case studies

  • Job search support 

  • CV review 

  • Interview preparation practice

  • Certificate awarded

  • Stand out from the crowd

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Introduction to Regulatory Affairs Course

Course details


Benefits of this course

• Live online classes and support for participants from anywhere in the world

• A comprehensive series of lectures on the fundamentals of regulatory affairs to get you up to track and ready to start work

• Course run by an expert teacher with experience working for large pharmaceutical companies and regulatory agencies

• Work experience assignments to give you real life regulatory experience. Work is reviewed by our experts and feedback is provided

• Support with looking for entry level regulatory affairs positions

• CV review to optimise your CV and increase your chances of getting an interview

• Interview preparation practice by live video to ensure you get the job. Run by experienced hiring managers from large pharmaceutical companies.


All of this will take you from having no experience in regulatory affairs to getting interviews and a career in regulatory affairs.


For the lecture part of the program, the following topics will be covered:

• What is the pharmaceutical industry?

• What is regulatory affairs?

• What is the role of the regulatory affairs professional?

• Background of medicines legislation

• Role and structure of the medicines agencies: EMA, FDA and MHRA (JDNA?)

• Marketing Authorisation Applications - full, abridged/ generics, hybrid, etc.

• EU regulatory procedures

• CTD - Module 1, 2, 3, 4, 5

• eCTD

• Labelling- SmPc, package leaflet and labels

• Clinical data summary (and full*)

• Non- clinical summary (and full*)

• Quality - chemistry manufacturing and controls

• Regulatory strategy

• Variations / lifecycle management - EU and FDA

• Clinical trial authorisations, IB*

• Response to agency questions*

• Agency meetings and scientific advice*

• Pharmacovigilance and risk management*

• Paediatrics*

• Orphan drug designation*

• Rest of world submissions*

• Q and A


Option 1 - half lectures, case studies - £465 (introductory offer for first 5 participants)



Option 2 - half lectures, work experience assignments, CV and interview help - £950 (introductory offer for first 5 participants)



Option 3 - *full lectures, case studies - £950

(introductory offer for first 5 participants)



Option 4 - *full lectures, case studies, work experience assignments, CV and interview help - £1595

(introductory offer for first 5 participants)



Case Studies - Working examples of each topic and how they apply to real life practice. It will give you the opportunity to deal with real world examples during the presentation


Work Experience Assignments - You will receive one assignment on each stage of the product lifecycle. This will enable you to gain entry level regulatory affairs experience





*Pharmacovigilance, orphan, paediatric or rest of world submissions


Start date**:

6th September for all options

2nd November for all options


For other dates contact


Invoice or pay online


Book a space in the course now. The introductory offer applies only to the first 5 bookings and will increase afterwards. The course will be fully booked once 10 participants are confirmed, so reserve your space now to avoid disappointment.

[Countdown of spaces left on first run of course]




Contact us for next year start dates or any questions relating to this course



**Although we do our best to keep start dates the same, they are subject to change