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Introduction to Regulatory Affairs Course

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.


This is the most comprehensive introductory 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 work experience to enhance your skills and job search support to secure a career in regulatory affairs.


The comprehensive lecture series covers the detailed regulatory requirements for pharmaceutical products in the EU, US and UK and an introduction to clinical regulatory affairs and medical device regulatory affairs.


In addition, you will obtain the hard to get real world work experience in regulatory affairs through course case studies and work experience assignments that can enhance your CV and improve your skills.


Following completion of the course you will benefit from job search support (CV review, interview preparation and job search support) to ensure you secure your career in regulatory affairs.


By joining you will also be part of an exclusive regulatory professional community that benefits from ongoing advice and support.


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


Invest in yourself and start your professional journey today.



Get in Touch

or use the live chat feature on the website


Full Course

£1389


Half Course

£689


Course Dates


Full Course Dates

March 2024 - 10 participants max

Live online webinar and recording option for remote access.

The course is held part time over a month.


Live Webinar on Saturday and Sunday 5 to 8pm (London Time)

- 16th and 17th March

- 23rd and 24th March

- 30th and 31st March

​Recording Available after the webinar


Work experience assignments will be assigned on non-lecture days between 16th and 31st March and will cover the broad concepts of the course e.g. clinical trials, marketing authorisation applications, variations, labelling and a specialist topic.


Other Dates

May 2024

July 2024

September 2024

November 2024


Half Course Dates

The half course recording will be available for viewing on-demand from April 2024.

This course can be done at your own pace.


Course Objective

To equip those with no or little regulatory affairs experience with the skills, knowledge and support to get a career in regulatory affairs.


Who is it for?

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 or expand your knowledge and skills to additional areas then this course is suitable for you.


Benefits of this course

  • On-demand and live online classes and support for participants from anywhere in the world

  • Comprehensive lecture series of more than 20 CPD hours on the fundamentals of regulatory affairs to get you up to speed and ready to start work

  • Course run by our experts who have considerable experience in pharmaceutical companies and regulatory health authorities

  • The only introductory course that covers EU, US and UK pharmaceutical regulatory affairs as well as specialist topics in clinical regulatory affairs, medical devices and pharmacovigilance.

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

  • Real world case studies in every lecture so you can apply your knowledge straight away

  • Admission to our exclusive regulatory professional community and ongoing job advice and support. Including, support with looking for entry level regulatory affairs positions

  • Expert CV review to enhance your CV, stand out from the crowd 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.

  • Receive a certificate and stand out from the crowd.


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


Course Outline / Lecture Programme

For the lecture part of the program, the topics below will be covered. The list is expandable. 23 CPD hours of lectures for full course students and 10 CPD hours of lectures for half course students.

Note: this list does not include all of the subtopics but is a summary of the subtopics to give you an idea of what you will learn. Each topic is one hour. The subtopics will cover one or numerous slides.


Topics highlighted in yellow below are available for the full course only. Those without a highlight are available for the full and half course.


Welcome and Course Overview Part 1 

  • What is regulatory affairs?

  • What is this course about?

  • Your regulatory journey

  • Course benefits, feedback, tutor experience

  • Half course vs. full course

  • What will you learn (detailed)

Welcome and Course Overview Part 2

Drug Development and What is Regulatory Affairs?

What is the Role of the Regulatory Affairs Professional? 

Background of Medicines Legislation - US, EU, UK  

EU and UK Regulatory Procedures Part 1

EU and UK Regulatory Procedures Part 2

US Regulatory Procedures  

Regulatory Control of Clinical Trials - EU, US 

EU and UK Marketing Authorisation Applications  

US New Drug Applications 

Variations and Lifecycle Management - EU, US 

Clinical Regulatory Affairs and Regulatory Writing Part 1

Clinical Regulatory Affairs and Regulatory Writing Part 2

Introduction to Medical Device Regulations - EU, US 

Introduction to Pharmacovigilance and Risk Management 

eCTD Content - Introduction and Module 1, Regional Administrative Information

eCTD Content - Module 2, Summaries

eCTD Content - Modules 3, Quality, CMC

eCTD Content - Modules 4 and 5, Non-clinical, Clinical

Labelling of Medicines in the EU and US Part 1

Labelling of Medicines in the EU and US Part 2

Regulatory Strategy 

Response to Agency Questions

Agency Meetings and Scientific Advice – US, EU, UK 


The programme above is the most accurate representation of what will be covered in the course. However, it is subject to change.


Services highlighted in yellow below are available for full course students only. Those without a highlight are available for full and half course students.


Case Studies

Each presentation in the lecture series includes case study scenarios which are discussed in the presentation. These are working examples of each topic and how they apply to real life practice. It will give you the opportunity to apply your knowledge to real world examples during the presentation.


Work Experience Assignments

Course work assignments that will give you real life regulatory work experience. Your assignments will be marked and you will need to complete these to receive your certificate. You will receive one assignment for each stage of the product lifecycle. This will enable you to gain entry level regulatory affairs experience. Work experience assignments covering the following topics will be provided:

  • Clinical Trials

  • Marketing Authorisation Applications

  • Variations

  • Labelling

  • Specialist Topic


Certificate

A certificate will be provided on completion of the course. The completion of this course can be included in your CV (certifications and training section) and covers more than 20 CPD hours.


CV Review

At the end of the course, you will update your CV to include this course and the work experience and skills gained. You can submit your CV for expert review and receive detailed feedback to enhance your CV, stand out from the crowd and increase your chances of getting an interview


Interview Preparation Practice

Once you are successful in your job application and gain an interview, you can participate in a mock live video interview with our experienced hiring manager to ensure your interview technique will enable you to get the job. Our experienced hiring managers have extensive experience in recruiting candidates for large pharmaceutical companies.


Exclusive Regulatory Professional Community

Ongoing Job Search Support

Upon signing up to the course you will gain admission into our exclusive regulatory professional community. Here you can socialise, ask questions and receive advice from each other and the course tutor. Within this community you will receive ongoing job advice and support. This Includes support with looking for entry level regulatory affairs positions


Course Tutor Profile

A UK registered pharmacist with around ten years of regulatory affairs experience gained from working in the UK regulatory health authority (MHRA) as an Assessor and several global pharmaceutical companies companies, such as, GSK, MSD and Bayer.​


Her experience covers the entire product lifecycle, from clinical trial applications through to new drug applications and post-approval changes. She has worked on various different medicinal products, including biologicals, vaccines, medical device combinations, consumer products (OTC), small molecule and generic medicinal products​.​​


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


She is passionate about regulatory affairs and providing exceptional regulatory support for pharmaceutical companies to accelerate innovation and deliver for patients. Furthermore, she is passionate about training other regulatory professionals in complex regulatory topics.


Further Information: About Us | Entry to Regulatory


Course Fees

Full Course

£1389


Half Course

£689


Feedback

Ms. T.A.​

Role obtained: Regulatory Affairs Officer (Medical Devices)

‘I can't recommend this service 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’

Mr. H Malik​

Role obtained: Project Coordinator (GSK)

‘This service 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!’

Ms. S.A.​

Interviews with AstraZeneca

‘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. I feel confident in my interviews’

Ms. D Rashid​

Attending interviews​​

‘I have been looking for a role in the pharmaceutical industry for a while so I used this service. The service is personal and highly informative. By the end of it, I have received many job interviews’

Book Your space - Start your Regulatory Journey

Book your space in the course now. The full course is limited to 10 participants per cohort due to the assignments that will be given and the job search support. The half course is available on demand for you to view at your convenience. Reserve your space now to avoid disappointment.

Full Course


Half Course


Get in Touch

or use the live chat feature on the website

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