Transcript Dr Nick Littlebury

Regulatory Affairs
Nick Littlebury
[email protected]
Wednesday 10th October 2012
Diamond BioPharm Limited, UK
What is Regulatory Affairs?
This career is not
simple to explain!
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LIASING WITH
STAKEHOLDERS
Regulatory Affairs
DRUG
LABELLING AND
LEAFLETS
Drug
X
CLINICAL
TRIALS
LICENCING & LEGAL
DOCUMENTS
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What is Regulatory Affairs?
Based on:
Manufacturing
Safety
Clinical & Non-Clinical
(e.g. TGN1412 –
catastrophic systemic
organ failure)
Efficacy
Clinical & Non-Clinical
- Does it work?
Quality
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An Example
Would you take a painkiller if . . .
... the side effect was a rash?
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An Example
Would you take a painkiller if . . .
... the side effect was an upset stomach?
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An Example
Would you take a painkiller if . . .
... the side effect was that your left leg fell off?
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An Example
Would you take a painkiller if . . .
... the side effect was that you might die?
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An example
• What if the painkiller was
changed to an end-of-life
cancer drug?
• Would you take the risks now?
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Benefit-Risk Balance
RISKS
BENEFITS
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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 . . .
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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
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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!
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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!
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Useful websites
• http://www.prospects.ac.uk/regulatory_affair
s_officer_job_description.htm
• http://www.topra.org/careers/whatregulatory-affairs
• http://ec.europa.eu/health/documents/eudral
ex/index_en.htm
• http://www.hma.eu/cmdh.html
• http://www.mhra.gov.uk/
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Positives and Negatives of Regulatory Affairs
Positives
Negatives
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
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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.
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Career Progression
• As move up the ladder:
More responsibilities
More accountability
More travel
Managing of staff
...
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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.
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Salary
Level 1
Salary
Banding*
Level 2
Level 3
Regulatory
Assistant
Regulatory
Officer
Publisher
Senior Officer Senior
Manager
QA Assistant
Principle
Officer
Admin support
for Regulatory
Affairs
Junior
Manager
£0-£20k
£20k-£50k
Manager
Level 4
Associate
Director
Director
Consultant Global Director
£40k-£80k
£60k-£150k+
* Taken from experience and not to be used as evidence for expected salaries
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Benefits
Varies from company to company, but may
include:
• Bonus
• Private healthcare
• Pension
• Company car (senior managers)
• Share options
• Gym membership
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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!
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Make a Difference
Imagine you are part of the team
that gets a new blockbuster
cancer drug into all the European
markets. . .
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Thank you!
Any questions?
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