Diamond BioPharm Limited, UK Regulatory Affairs Nick Littlebury nlittlebury@diamondpharmaservices.com Wednesday 10th October 2012 Diamond BioPharm Limited, UK

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

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

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

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

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

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

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

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

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

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

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

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

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

Diamond BioPharm Limited, UK Useful websites 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/ Diamond BioPharm Limited, UK

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

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

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

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

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

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

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

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

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