Senior Director, Intl Regulatory Affairs Geo-Expansion
Core
Senior Director leading global regulatory strategy for Vertex's international markets (EU, UK, CH, ROW), overseeing development programs in emerging disease areas and registered medicines.
Role type
Senior Director, International Regulatory Strategy
Builds
Global regulatory strategies, submission documents, and Health Authority communications for Vertex medicines.
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
International regulatory strategy, regulatory submissions, stakeholder management (EMA, national authorities), cross-functional leadership, project management, process improvement, team coaching, regulatory science expertise
Preferred skills
Masters-level or Ph.D. degree, extensive supervisory/management experience
Technologies
Regulatory frameworks, global/regional/local legislation, clinical development requirements
Responsibilities
Develop international regulatory strategy for complex projects; Represent GRA on core development teams; Advise senior management on global strategies; Manage project plans and resources; Influence regulatory environment via industry meetings; Lead continuous improvement of department processes; Manage GRA functional team members
Seniority
Senior Director, strategic leadership & team management