Regulatory Strategy and Global Regulatory Lead

1. Defining and executing global regulatory strategy for early and late stage development of human medicinal products
2. Global regulatory leadership and management of multi-disciplinary teams, including large complex projects such as marketing authorisation applications/new drug applications
3. Support of due diligence activities

Global Regulatory Submissions and Health Authority Interactions

1. Preparing for and leading of regulatory interactions, such as Scientific Advice procedures and pre-submission meetings.
2. Authoring and review of regulatory submission documents, including:
   • Common technical documents for regulatory and clinical sections
   • Paediatric investigation plans
   • Orphan medicinal product applications
   • Briefing packages for agency meetings
   • Clinical trial applications
   • Summary of product characteristics/company core data sheet