Regulatory Affairs

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Regulatory Affairs. Nick Littlebury nlittlebury@diamondpharmaservices.com Wednesday 10 th October 2012. What is Regulatory Affairs?. This career is not simple to explain!. LIASING WITH STAKEHOLDERS. EU & INTNL COUNTRIES. MANUFACTURE. Regulatory Affairs. DRUG LABELLING AND LEAFLETS. - PowerPoint PPT Presentation

Text of Regulatory Affairs

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Diamond BioPharm Limited, UK

Regulatory AffairsNick Littleburynlittlebury@diamondpharmaservices.com

Wednesday 10th October 20122Diamond BioPharm Limited, UK

What is Regulatory Affairs?This career is not simple to explain!

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Regulatory Affairs

CLINICAL TRIALS

Drug XDRUG LABELLING AND LEAFLETS

MANUFACTURE

LIASING WITH STAKEHOLDERS

LICENCING & LEGAL DOCUMENTS

EU & INTNL COUNTRIES

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What is Regulatory Affairs?Based on:QSE

ualityafetyfficacyManufacturingClinical & Non-Clinical (e.g. TGN1412 catastrophic systemic organ failure)Clinical & Non-Clinical- Does it work?5Diamond BioPharm Limited, UK

An ExampleWould you take a painkiller if . . .... the side effect was a rash?

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An ExampleWould you take a painkiller if . . .... the side effect was an upset stomach?

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An ExampleWould you take a painkiller if . . .... the side effect was that your left leg fell off?8Diamond BioPharm Limited, UK

An ExampleWould you take a painkiller if . . .... the side effect was that you might die?

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An exampleWhat 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

RISKSBENEFITS11Diamond BioPharm Limited, UK

What does a Regulatory Affairs person do?Interact with health authorities from all over the worldCollate evidence for marketing applications presented in a dossierInteract with manufacturing sitesWrite documentsCo-ordinate application and variation submissionsAnd much, much more . . .12Diamond BioPharm Limited, UK

What qualifications do I need?Generally 2:1 BSc (hons)No hard and fast rulesPreferably from a Chemistry, Pharmacy or Lifescience background.Companies like applicants with further study qualifications masters, PhDs13Diamond BioPharm Limited, UK

Analytical skillsOrganisational skillsTime management skillsInterpersonal-skillsQuick learnerICT skills. . .What skills do I need?All of which are transferrable from research!How to prepare your CV14Diamond BioPharm Limited, UK

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!

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http://www.prospects.ac.uk/regulatory_affairs_officer_job_description.htm http://www.topra.org/careers/what-regulatory-affairshttp://ec.europa.eu/health/documents/eudralex/index_en.htm http://www.hma.eu/cmdh.htmlhttp://www.mhra.gov.uk/

Useful websites16Diamond BioPharm Limited, UK

Positives and Negatives of Regulatory AffairsPositivesNegativesEver-changing legislation and so always learningCan be stressfulChallengingCant always take time with decisionsTravelDifficult whilst learning early on in career due to the sheer volume of legislationGood salary and associated lifestyle17Diamond BioPharm Limited, UK

Level 1Level 2Level 3Level 4Regulatory AssistantRegulatory OfficerManagerAssociate DirectorPublisherSenior OfficerSenior ManagerDirectorQA AssistantPrinciple OfficerConsultantGlobal DirectorAdmin support for Regulatory AffairsJunior ManagerCareer PathNot 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. 18Diamond BioPharm Limited, UK

As move up the ladder:More responsibilitiesMore accountabilityMore travelManaging of staff . . .Career Progression19Diamond BioPharm Limited, UK

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 Scale20Diamond BioPharm Limited, UK

SalaryLevel 1Level 2Level 3Level 4Regulatory AssistantRegulatory OfficerManagerAssociate DirectorPublisherSenior OfficerSenior ManagerDirectorQA AssistantPrinciple OfficerConsultantGlobal DirectorAdmin support for Regulatory AffairsJunior ManagerSalary Banding*0-20k20k-50k40k-80k60k-150k+* Taken from experience and not to be used as evidence for expected salaries21Diamond BioPharm Limited, UK

Varies from company to company, but may include:BonusPrivate healthcarePensionCompany car (senior managers)Share optionsGym membershipBenefits22Diamond BioPharm Limited, UK

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!

Summary23Diamond 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. . .24Diamond BioPharm Limited, UK

Thank you!Any questions?