Head of Regulatory Strategy and Policy

Accenian are currently supporting a Global Pharmaceutical company to secure a Head of Regulatory Strategy and Policy.

This role entails:

  • Providing leadership to regulatory strategy and policy value stream and assist Head of Regulatory Affairs, determining optimum strategies for new marketing authorisation applications.
  • Monitor the regulatory landscape to review and shape strategy and policy activities.
  • Leadership of the regulatory strategy and policy value stream – coordinating reviews, information gathering, providing technical input and regular communication to the EU region.
  • Support the obtaining of marketing authorisations for products in designated EU and non-EU territories.
  • Lead a team of Regulatory Managers and Senior Regulatory Managers. Set objectives, conduct reviews, ensure training, development and coaching of team.
  • Lead activities for new MAAs for the EU region, provide competitive advantage and meet market entry requirements enabling on-time launches, submission fees, choice of RMS, and choice of MAH.

You must:

  • Hold a BSc degree in a scientific discipline
  • Brilliant knowledge of regulations, policies, procedures, drug dev guidelines and EU compliance.
  • Track record of successful interactions with EU health authorities on post marketed products.
  • Able to manage risk and escalate issues
  • Proven experience managing relationships with clients and contractors.

If you are interested in applying for this role then please send your CV to daniela.foster-turner@accenian.com