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Director of Regulatory Affairs

3 months ago

Nottingham, United Kingdom Walker Cole International Full time

Walker Cole International is searching for a Regulatory Affairs Director, Europe to join a biopharmaceutical company with a global presence. The Regulatory Affairs Director, Europe will drive regional strategy and deliver hands-on regulatory submissions to clinical assets.


As the Regulatory Affairs Director, Europe you will be responsible for the following:


  • Lead regulatory activity for the European and Rest of World regions.
  • Develop and deliver regional regulatory strategy.
  • Partner with R&D, Clinical and CMC to drive product development.
  • As the Regulatory Affairs Director, Europe you will be lead regulatory excellence on submissions, documentation and health authority engagement.
  • As a member of the European senior management team, you will be a figure head for the wider business.


To be a successful applicant for the Regulatory Affairs Director, Europe you will demonstrate the following:


  • Science graduate. MSc or PhD would be desirable.
  • Proven biopharmaceutical industry expertise.
  • Track record of Regulatory Affairs work experience for biopharmaceutical / biologics regulations.
  • Previous experience of European (EMA) and UK (MHRA) regulatory affairs is essential.
  • Weekly travel to South East of England is required.


Regulatory Affairs Director | Associate Regulatory Affairs Director Europe | EU | EMEA | Head of Regulatory Affairs | Regulatory Affairs Director Europe | Pharmaceutical | Biologics | Biopharmaceutical