Global Regulatory Affairs Portfolio Lead, Marketed Products, Radiopharma
Core
Oversees registration and lifecycle maintenance of a portfolio of marketed radiopharmaceutical product Marketing Authorizations globally.
Role type
Senior Global Regulatory Affairs Portfolio Lead
Builds
Global regulatory strategies and lifecycle management for marketed radiopharmaceutical products
Domain
Pharmaceutical Diagnostics / Radiopharmaceuticals
Required skills
Global regulatory strategy, post-approval lifecycle management, cross-functional team leadership, external agency interfacing, regulatory budget planning, stakeholder influence
Preferred skills
Radiopharmaceutical sector experience, digital technologies adoption, AI-driven solutions
Technologies
Regulatory Information Management systems
Responsibilities
Oversee regulatory activities including variations and renewals; provide strategic input into commercial plans; ensure compliance with global regulatory requirements; lead forums for sharing best practices; interpret external regulatory environment for portfolio optimization; contribute to regulatory budget process
Seniority
Senior, hands-on IC with strategic oversight