Regulatory Affairs

Diamond BioPharm Limited, UK

Regulatory Affairs

Nick [email protected]

Wednesday 10th October 2012

mailto:[email protected]

2Diamond BioPharm Limited, UK

What is Regulatory Affairs?

This career is not simple to explain!


Regulatory Affairs

CLINICAL TRIALS

Drug X

DRUG LABELLING AND LEAFLETS

MANUFACTURE

LIASING WITH STAKEHOLDER

S

LICENCING & LEGAL

DOCUMENTS

EU &

INTNL

COUNTRIES


What is Regulatory Affairs?

Based on:QSE

ualityafetyfficacy

Manufacturing

Clinical & Non-Clinical (e.g. TGN1412 –

catastrophic systemic organ failure)

Clinical & Non-Clinical- Does it work?


An ExampleWould you take a painkiller if . . .

... the side effect was a rash?



... the side effect was an upset stomach?



... the side effect was that your left leg fell off?



... the side effect was that you might die?


An example• What if the painkiller was

changed to an end-of-life cancer drug?

• Would you take the risks now?


Benefit-Risk Balance

RISKS

BENEFITS


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 . . .


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


• Analytical skills• Organisational skills• Time management skills• Interpersonal-skills• Quick learner• ICT skills• . . .

What skills do I need?

All of which are transferrable from

research!

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 chanceShow that you are interestedAttend 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!


• http://www.prospects.ac.uk/regulatory_affairs_officer_job_description.htm

• http://www.topra.org/careers/what-regulatory-affairs

• http://ec.europa.eu/health/documents/eudralex/index_en.htm

• http://www.hma.eu/cmdh.html• http://www.mhra.gov.uk/

Useful websites

http://www.prospects.ac.uk/regulatory_affairs_officer_job_description.htm



http://www.topra.org/careers/what-regulatory-affairs

http://www.topra.org/careers/what-regulatory-affairs

http://ec.europa.eu/health/documents/eudralex/index_en.htm



http://www.hma.eu/cmdh.html

http://www.hma.eu/cmdh.html

http://www.mhra.gov.uk/

http://www.mhra.gov.uk/


Positives and Negatives of Regulatory Affairs

Positives NegativesEver-changing legislation and so

always learningCan be stressful

Challenging Can’t always take time with decisions

TravelDifficult whilst learning early on

in career due to the sheer volume of legislation

Good salary and associated lifestyle


Level 1 Level 2 Level 3 Level 4Regulatory Assistant

Regulatory Officer

Manager Associate Director

Publisher Senior Officer Senior Manager

Director

QA Assistant Principle Officer Consultant Global DirectorAdmin support for Regulatory Affairs

Junior Manager

Career Path

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.


• As move up the ladder:More responsibilitiesMore accountabilityMore travelManaging of staff . . .

Career Progression


• 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.

Salary Scale


SalaryLevel 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


Varies from company to company, but may include:• Bonus• Private healthcare• Pension• Company car (senior managers)• Share options• Gym membership

Benefits


• 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!

Summary


Make a DifferenceImagine you are part of the

team that gets a new blockbuster cancer drug into all the European markets. . .


Thank you!

Any questions?

Documents

Regulatory Affairs