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Regulatory Affairs: A guide

Source: NonStop Recruitment
Published: 01/11/09
The Regulatory Affairs function within the industry is the interface between Commercial Organisations (Pharma, Biotech, Biopharmas/Biologics, CRO’s, OTC, Generics and Medical Devices), and Regulatory Authorities in order to approve Registrations/Marketing and Manufacturing Authorisations, Maintenance of Products and Clinical Trials Authorisations.

Career Path:

Initially:
  • Regulatory Entry Level/Junior Associate
Subsequently:
  • Regulatory Affairs Associate/Officer
  • Regulatory Affairs Executive
  • Senior Regulatory Affairs Executive/Associate/Officer
  • Regulatory Project Manager (no Line Management responsibility)
  • Regulatory Affairs Manager (Line Management)
  • Senior Regulatory Manager
  • Associate Director, Regulatory Affairs
  • Director, Regulatory Affairs
  • Head of Regulatory Affairs (Unit)
  • Senior Director, Regulatory Affairs
  • Head of Regulatory Affairs (Division)
  • Vice President, Regulatory Affairs
  • Senior Vice President, Regulatory Affairs (Global Head)
All of the above pertains to non-CMC and CMC roles.

'Interesting information':

Depending on the organisation, some Regulatory roles can be very broad and give the candidate an excellent overview of the whole Drug Development Life-cycle in general in terms of R & D, Pre-Clinical, Clinical (Phases I, II and III), Registration and Post Marketing/Commercialisation – these are coveted roles; however, in larger onganisations, due to the volume of work involved, staff can find themselves more compartmentalised (e.g. Clinical Regulatory or Registrations and Post Marketing). For example, generally, but not always, CRO’s are more involved in Clinical Regulatory (CTA’s, IMPD’s, Protocols, Clinical Regulatory up-dates, and End of Trail Notifications) whilst Generics and OTC are more involved from MAA’s/Registrations - National Submissions/Mutual Recognition Procedure (MRP), DeCentralised Procedure (DCP), and sometimes, Centralised Procedure (CP), onwards, as per post-patent expiry. Biotech/Biologic Companies have to Register all Drugs through Centralised Procedure in 27 countries at once.

Functions within the area are:
  • R & D and Pre-Clinical (small)
  • Clinical Regulatory (CTA’s, IMPD’s, Clinical up-dates, Protocols and End of Trial Notifications)
  • Registrations (Compiling CTD/Dossiers for MAA’s and Registrations – National Submissions/MRP, DCP and CP)
  • Post marketing (Variations, Renewals, Line extensions etc.)
  • Labelling, PIL’s, User testing and SmPC’s
  • CMC (Chemistry, Manufacturing & Controls – the Quality side of Regulatory, incorporating ingredients and manufacturing)
  • Regulatory Strategy & Intelligence
  • Regulatory Publishing and ePublishing (formatting for Submission – generally more of an IT-based function)
  • Project Management
  • Product Development
3 main Regulatory bodies to remember are:
  • MHRA (UK)
  • EMEA (Europe)
  • FDA (USA)
Geography – where are the roles based?

In the UK –
  • Berkshire
  • Buckinghamshire
  • Surrey
  • Hampshire
  • Middlesex
  • Hertfordshire
  • Cambridgeshire
  • Bedfordshire
  • Central London
  • Cheshire/Manchester
  • East Yorkshire
In Europe -
  • Basel – Switzerland
  • Paris
  • Germany – diverse
  • Other European countries
What do you need to do to get involved in this area?

Apart from the obvious of having personal contacts within Regulatory Affairs:
  • A good Life Sciences Degree
  • An MSc in Regulatory Affairs (University of Wales in the UK, and various French/Swiss Universities are the best)
  • A 3-6 month Regulatory Affairs Internship/Traineeship at either a ‘blue-chip’ Pharma, or, at a Regulatory body such as the EMEA in Docklands



NonStop Recruitment is a market leader in pharmaceutical Recruitment with specialist consultants covering major markets such as UK, Germany, Switzerland, France, Italy and the Netherlands. These consultants recruit for all major roles within the pharmaceutical industry, including clinical research, quality assurance, sales and marketing, pharmacovigilance, business development and regulatory affairs.
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