Darren Whyte, Senior Consultant - Regulatory Affairs, ProClinical Ltd, UK
Unlike most vocations within the Pharmaceutical Industry, entry into a career in Regulatory Affairs does not have a set pattern or follow a natural progression. There are rarely graduate entry, internships or work placements on offer, yet a move into Regulatory Affairs is considered as challenging, exciting and offers a rewarding (financially and personally) career.
I undertook a quick survey of 200 Regulatory professionals based in the UK with 2 to 5 years experience to find out how they entered a career in Regulatory Affairs and what route they took to get there. Below is a list of the 200 candidate’s previous roles before moving into RA:
Quality (Assurance, Control, Systems) Role: 17.5%
Clinical (Research, Trials, Project Manager) Role: 7%
Internships: 5.5%
MHRA (Scientific Classifier, Labelling, Variations Division): 16%
Health / Government / Regulatory Agencies (EMEA, ABPI): 4%
Database Coordinators, Data entry: 7.5%
Straight in from University into a RA Associate role: 10%
Pharmacist Locum/ Medical Information Professional/ PVG: 12%
Scientist (Analytical, Formulation, Research etc): 17%
Other (Legal, Patent, Health Economics, Business): 3.5%
Firstly, these results potentially do not represent the Regulatory Industry as a whole, but I do think we can take a few points from it.
The figures highlight that to start a role within the MHRA (or alternative Regulatory/ Health Authority) or within Quality can often open doors for you to move into Regulatory Affairs. The Quality professionals had a stronger affiliation with Medical Device based companies.
The Scientists who moved into Regulatory Affairs were often working at Global Pharmaceutical organisations and were, in general, Research, Formulation and Analytical Scientists.
The candidates that moved straight into Regulatory Affairs from university often moved to small to mid size pharmaceutical, generic and device based companies. The Clinical candidates that moved into Regulatory Affairs all moved internally within CRO’s. 2% of the
candidates came from a Project Manager role and experienced a reduce in salary in order to make the move.
The Pharmacists/ Medical Information/ PVG staff had the most diverse entrance into Regulatory Affairs with more candidates going into Regulatory Operations in comparison with the other groups.