Introduction to Regulatory Affairs Course
Kick-start your Regulatory Affairs Career in 30 Days
Introduction to Regulatory Affairs Course
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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.
Enrol in the most comprehensive regulatory affairs introductory course available, which includes regulatory work experience, on-demand lecture recordings, case studies, job search support until you get a role, expert help with your CV and a mock interview.
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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 have a more comprehensive knowledge of it, then this course is for you.​
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This is the most comprehensive regulatory affairs course available, covering regulatory requirements for Europe, America and the UK from clinical trial applications through to marketing authorisation applications and variations, giving you 40+ CPD hours of learning and a certificate. In addition to this strong foundational knowledge, you will obtain hard-to-get real world work experience to enhance your skills, as well as job support to secure your career in regulatory affairs.
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The work experience assignments involve real-life regulatory work tasks that you will complete. Furthermore, our expert will review your CV or resume and provide you with a mock interview to ensure you land your first regulatory affairs role. You will also get exclusive access to tailored job search support, where we show you where to apply, give you advice to make you stand out and recommend opportunities to you. We will support you until you get your first role.
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This course is run by our experts who are former Health Authority regulators with considerable experience in pharmaceutical companies such as GSK and MSD.
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We have made this course part-time with on-demand recordings to fit around your work or studies, and remote, so you can access the lectures whenever you want and from wherever you are.
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Why not take a look at the course brochure for further details and fill in the form below to access free course materials. I look forward to supporting your regulatory career.
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Want to get free access to the first two lectures, sample case study and work assignment?
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Next Course Date: 26th January 2025
BONUS Training on Clinical Regulatory Strategy
(worth £99) for January cohort only
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Course held part time over a month​
On-Demand Recordings with Live Support
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Limited to 15 Spaces per cohort
Get Free Course Material & Exclusive Updates
If you are interested in investing in yourself and starting your professional journey in regulatory affairs, fill in the form below to access free course material now (first two lectures of the course, sample case study and work experience assignment) and get exclusive information, discounts and updates about the course.
Take advantage of this offer and kick-start your career in regulatory affairs.
Our experts have worked with the following organisations
Do You Have Any Questions?
Speak to us about your career goals and any questions you have about the course.
We look forward to hearing from you.
Or send us an email
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.
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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.
Why Regulatory Affairs?
Make a
Difference
Make a difference to the lives of millions of patients across the world who rely on lifesaving medicines.
Make A
Difference
Great Career Prospects
The usual starting salary is
£30-40k.
This rises to £50-70k for managers,
and then increases to
£100k+ as you gain more
experience
Great Career Prospects
Interesting
Professionals gain knowledge of regulations, pharmaceutical science and commercial strategy.
With constantly evolving technology and regulations, there is always something new to learn
Can specialise in a specific area
Interesting
Job Stability
Medicines regulations around the world are increasing.
Increasing regulations means a higher demand for regulatory affairs professionals.
There are many jobs available for experienced professionals
Job Stability
Flexible
Working
Most jobs allow working from home for 2-3 days a week.
Some roles are homebased.
Hours are flexible as long as core hours (10am-3pm) are adhered to.
Part time work is available.
Flexible
Working
Full Intro to Reg Course
Comprehensive Lecture Series
CV review
Certificate
EU, UK and US Regulations
Job Search Support
Exclusive Community
On-Demand Recordings & Live Support
Real World Case Studies
Expert Tutors
Work Experience Assignments & Project
Interview Preparation Practice
40+ CPD Hours
​Half Course
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11+ CPD Hours of Learning
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EU, UK and US Regulations
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Certificate on Completion
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Real World Case Studies
​EU or US Course
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30+ CPD hours of learning
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EU, UK OR US Regulations
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Certificate on Completion
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Real World Case Studies
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Work Experience (2 weeks)
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CV Review
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Course Book
​Full Course
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40+ CPD hours of Learning
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EU, UK and US Regulations
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Certificate on Completion
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Real World Case Studies
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Work Experience (4 weeks)
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Work Experience Project **
(1 month, part-time) -
CV Review
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Mock Interview
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Job Search Support*
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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
Want to get free access to the first two lectures, sample case study and work assignment?
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FAQ Coming Soon
FAQs Coming Soon
Half Course
Available Now​
(Part time, to fit around your work and studies)
Covers European, UK and American medicines regulations from clinical trial stage through to marketing authorisation applications and variations .
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Choose if: you want a baseline knowledge of regulatory affairs and a course certificate
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Certificate (with topics learnt)
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Recordings for viewing on-demand.
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Access granted straight away
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Study at your own pace.
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Case studies with answers
Course Dates & Info
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Europe or American Regulations Course
Available Now​
(Part time over two weeks, to fit around your work and studies)
Covers either European and UK or American medicines regulations from clinical trial stage through to marketing authorisation applications and variations. In addition, you will get two weeks of regulatory work experience, your CV reviewed by our expert and lectures covering specialist regulatory topics and CTD structure. You will get email support for any questions you have.
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Choose if: you want a detailed knowledge of regulatory affairs for either European and UK or American regulations, a course certificate, your CV reviewed and two weeks of regulatory work experience for your CV.
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Two weeks of regulatory work experience assignments. Set each weekend and due the following weekend. Answers will be provided. Regulatory work reference to add to your CV.
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Review of your CV so you can apply for entry level roles
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Certificate (with topics learnt)
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Recordings for viewing on-demand
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Access granted straight away
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Email support for any questions you have
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Lecture recordings released each weekend, giving you one week to view them before the next set are released.
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Case studies with answers. ​​​
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Full Course Cohorts
​26th January 2025
(Part time over one to two months, to fit around your work and studies)
Covers European, UK and American medicines regulations from clinical trial stage through to marketing authorisation applications and variations. In addition, you will get one to two months of regulatory work experience, job search support (where to apply, how, advice and recommendations) until you get your first role, your CV reviewed by our expert, a mock interview and lectures covering specialist regulatory topics and CTD structure. You will get live support for your questions.
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Choose if: you want a detailed knowledge of European,UK and American regulations, a course certificate, your CV reviewed, a mock interview with feedback, one to two months of regulatory work experience for your CV, job search support until you get a job.
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One month of regulatory work experience assignments. Set each weekend and due the following weekend. Answers will be provided. Regulatory work reference to add to your CV.
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Subject to availability, a further one month work experience project after the course for you to obtain more regulatory work experience.
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Review of your CV so you can apply for entry level roles.
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Job search support until you get a job (where to apply, how to apply, specific advice, recommendation of jobs, job search resources and information)
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Expert run mock interview and feedback to ensure you secure the role.
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Exclusive professional community for support
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Certificate (with topics learnt)
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Recordings for viewing on-demand
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Live Support for any questions you have in the cohort group chat
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Lecture recordings will be released each weekend, giving you one week to view them before the next set are released.
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Case studies with the answers.
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Future Cohorts
January 2025
March 2025
May 2025
July 2025
September 2025
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Our Feedback Is Outstanding
‘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]
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]
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]
Regulatory Affairs placement offer from GSK
(Biochemistry Degree)
Sample Lectures
What is Regulatory Affairs? Sample Video 1
What is in a Marketing Authorisation Application? Sample Video 2
Want to get free access to the first two lectures, sample case study and work assignment?
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Full Course Details
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
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A life changing course that improves your career prospects in regulatory affairs by supporting you to get an entry level role. Experienced regulatory affairs professionals can earn over £100,000 per year.
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On-demand recorded classes and live support for participants from anywhere in the world
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Comprehensive lecture series of more than 40+ CPD hours of learning on the fundamentals of regulatory affairs to get you up to speed and ready to start work
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Course run by our experts who have considerable experience in pharmaceutical companies and regulatory health authorities
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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.
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Work experience assignments to give you real life regulatory experience. Work is reviewed by our experts and feedback is provided
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Real world case studies in every lecture so you can apply your knowledge straight away
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Admission to our exclusive regulatory professional community and ongoing job advice and support. Including, support with looking for entry level regulatory affairs positions
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Expert CV review to enhance your CV, stand out from the crowd and increase your chances of getting an interview
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Interview preparation practice by live video to ensure you get the job. Run by experienced hiring managers from large pharmaceutical companies.
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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.
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Course Outline / Lecture Programme
For the lecture part of the program, the topics below will be covered. View the course brochure for the full list of subtopics. There is 21 CPD hours of lectures for the full course and an additional 19 hours of work experience assignments.
There are 11 CPD hours of lectures for the half course.
Topics highlighted in yellow below are available for the full course only. Those without a highlight are available for both courses.
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Welcome and Course Overview Part 1
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Welcome and Course Overview Part 2
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Drug Development and What is Regulatory Affairs?
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What is the Role of the Regulatory Affairs Professional?
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Background of Medicines Legislation - US, EU, UK
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EU and UK Regulatory Procedures Part 1
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EU and UK Regulatory Procedures Part 2
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US Regulatory Procedures
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Regulatory Control of Clinical Trials - EU, US
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EU and UK Marketing Authorisation Applications
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US New Drug Applications
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Variations and Lifecycle Management - EU, US
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Clinical Regulatory Affairs and Regulatory Writing Part 1
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Clinical Regulatory Affairs and Regulatory Writing Part 2
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Introduction to Medical Device Regulations - EU, US
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Introduction to Pharmacovigilance and Risk Management
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eCTD Content - Introduction and Module 1, Regional Administrative Information
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eCTD Content - Module 2, Summaries
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eCTD Content - Modules 3, Quality, CMC
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eCTD Content - Modules 4 and 5, Non-clinical, Clinical
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Labelling of Medicines in the EU and US Part 1
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Labelling of Medicines in the EU and US Part 2
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Regulatory Strategy
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Response to Agency Questions
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Agency Meetings and Scientific Advice – US, EU, UK ​
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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:
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Clinical Trials
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Marketing Authorisation Applications
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Variations
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Specialist Topic (e.g. clinical regulatory affairs, medical devices or labelling)
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After the course, there will be a further work experience project for you to obtain more regulatory work experience.
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 40+ CPD hours of learning.
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
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Book Your space - Start your Regulatory Journey
Book your space in the course now. The full course is limited to 10 -15 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.
Course Leader
Rabiea, Principal Regulatory Consultant and Managing Director
I am 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.
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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 different medicinal products, including biologicals, vaccines, medical device combinations, consumer products (OTC), small molecule and generic medicinal products​.
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I have 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​.
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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 professionals in complex regulatory topics.
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Register Your Interest, Receive Free Course Material & Get Exclusive Updates
If you are interested in investing in yourself and starting your professional journey in regulatory affairs, fill in the form below to receive free course material now (first two lectures of the course, sample case study and work experience assignment) and get exclusive information and updates about the course.
Take advantage of this offer and kick-start your career in regulatory affairs.