Senior Director, Intl Regulatory Affairs Geo-Expansion
Core
Senior Director leading global regulatory strategy for Vertex's international markets (EU, UK, CH, ROW) across emerging disease areas and registered medicines.
Role type
Senior Director, Regulatory Strategy (International)
Builds
Global regulatory strategies, submission documents, and Health Authority communications for international markets.
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Required skills
International regulatory strategy, regulatory submissions, stakeholder management (EMA, national authorities), cross-functional leadership, project management, regulatory intelligence, team management, pharmaceutical R&D knowledge.
Preferred skills
Masters-level or Ph.D. degree, extensive supervisory/management experience.
Technologies
Regulatory frameworks, submission documents, SOPs.
Responsibilities
Develop international regulatory strategy; lead project plans and timelines; represent GRA on core development teams; advise senior management; influence regulatory environment via industry meetings; lead continuous improvement of department processes; manage GRA functional teams.
Seniority
Senior Director, strategic leadership and team management.