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