1. Diamond BioPharm Limited, UK
Regulatory Affairs
Nick Littlebury
Wednesday 10th October 2012
Diamond BioPharm Limited, UK

2. What is Regulatory Affairs?
This career is not simple to explain!
Diamond BioPharm Limited, UK

3. Regulatory Affairs EU & INTNL COUNTRIES LIASING WITH STAKEHOLDERS
MANUFACTURE
Regulatory Affairs
Drug X
DRUG LABELLING AND LEAFLETS
CLINICAL TRIALS
LICENCING & LEGAL DOCUMENTS
Diamond BioPharm Limited, UK

4. What is Regulatory Affairs?
Based on: Q S E
Manufacturing
Clinical & Non-Clinical (e.g. TGN1412 – catastrophic systemic organ failure)
uality
afety
Clinical & Non-Clinical
- Does it work?
fficacy
Diamond BioPharm Limited, UK

5. Diamond BioPharm Limited, UK
An Example
Would you take a painkiller if . . .
... the side effect was a rash?
Diamond BioPharm Limited, UK

6. Diamond BioPharm Limited, UK
An Example
Would you take a painkiller if . . .
... the side effect was an upset stomach?
Diamond BioPharm Limited, UK

7. Diamond BioPharm Limited, UK
An Example
Would you take a painkiller if . . .
... the side effect was that your left leg fell off?
Diamond BioPharm Limited, UK

8. Diamond BioPharm Limited, UK
An Example
Would you take a painkiller if . . .
... the side effect was that you might die?
Diamond BioPharm Limited, UK

9. Diamond BioPharm Limited, UK
An example
What if the painkiller was changed to an end-of-life cancer drug?
Would you take the risks now?
Diamond BioPharm Limited, UK

10. Diamond BioPharm Limited, UK
Benefit-Risk Balance
RISKS
BENEFITS
Diamond BioPharm Limited, UK

11. What does a Regulatory Affairs person do?
Interact with health authorities from all over the world
Collate evidence for marketing applications presented in a dossier
Interact with manufacturing sites
Write documents
Co-ordinate application and variation submissions
And much, much more . . .
Diamond BioPharm Limited, UK

12. What qualifications do I need?
Generally 2:1 BSc (hons)
No hard and fast rules
Preferably from a Chemistry, Pharmacy or Lifescience background.
Companies like applicants with further study qualifications – masters, PhDs
Diamond BioPharm Limited, UK

13. What skills do I need? Analytical skills Organisational skills
Time management skills
Interpersonal-skills
Quick learner
ICT skills
. . .
All of which are transferrable from research!
Diamond BioPharm Limited, UK

14. Diamond BioPharm Limited, UK
How to prepare your CV
Regulatory affairs is a stand alone career
Advice would be to:
Research thoroughly before you apply to give yourself the best chance
Show that you are interested
Attend pharmaceutical conferences to keep up-to-date with the latest developments
Regulatory courses are available through TOPRA but the cheapest and easiest is to thoroughly research the career!
Diamond BioPharm Limited, UK

15. Diamond BioPharm Limited, UK
Useful websites
Diamond BioPharm Limited, UK

16. Positives and Negatives of Regulatory Affairs
Ever-changing legislation and so always learning
Can be stressful
Challenging
Can’t always take time with decisions
Travel
Difficult whilst learning early on in career due to the sheer volume of legislation
Good salary and associated lifestyle
Diamond BioPharm Limited, UK

17. Career Path Level 1 Level 2 Level 3 Level 4 Regulatory Assistant
Regulatory Officer
Manager
Associate Director
Publisher
Senior Officer
Senior Manager
Director
QA Assistant
Principle Officer
Consultant
Global Director
Admin support for Regulatory Affairs
Junior Manager
Not all roles are covered. Role definition is specific to individual companies. The term Officer is often interchangeable with the term Associate or Executive. The terms Team Leader and Regulatory Lead also have different definitions within individual companies.
Diamond BioPharm Limited, UK

18. Diamond BioPharm Limited, UK
Career Progression
As move up the ladder:
More responsibilities
More accountability
More travel
Managing of staff
. . .
Diamond BioPharm Limited, UK

19. Diamond BioPharm Limited, UK
Salary Scale
Very much depends on the company.
An ‘Officer’ in Company A may earn more than a ‘Senior Officer’ in Company B, whilst a ‘Principal Officer in Company C might earn more than a ‘Senior Manager’ in Company D.
Early in career, experience is more important than salary – have to be astute.
Diamond BioPharm Limited, UK

20. Diamond BioPharm Limited, UK
Salary
Level 1
Level 2
Level 3
Level 4
Regulatory Assistant
Regulatory Officer
Manager
Associate Director
Publisher
Senior Officer
Senior Manager
Director
QA Assistant
Principle Officer
Consultant
Global Director
Admin support for Regulatory Affairs
Junior Manager
Salary Banding*
£0-£20k
£20k-£50k
£40k-£80k
£60k-£150k+
* Taken from experience and not to be used as evidence for expected salaries
Diamond BioPharm Limited, UK

21. Diamond BioPharm Limited, UK
Benefits
Varies from company to company, but may include:
Bonus
Private healthcare
Pension
Company car (senior managers)
Share options
Gym membership
Diamond BioPharm Limited, UK

22. Diamond BioPharm Limited, UK
Summary
Regulatory affairs is an interesting, challenging and rewarding career.
The salary, benefits and career prospects are very good once you have got your foot in the door.
Research the career thoroughly and get applying!
Diamond BioPharm Limited, UK

23. Diamond BioPharm Limited, UK
Make a Difference Imagine you are part of the team that gets a new blockbuster cancer drug into all the European markets. . .
Diamond BioPharm Limited, UK

24. Diamond BioPharm Limited, UK
Thank you!
Any questions?
Diamond BioPharm Limited, UK