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 [email protected]