Global Head, Regulatory Affairs – Labeling (PDx)

Job Description

The Global Head, Regulatory Affairs – Labeling sets the enterprise labeling vision and delivers the strategic labeling agenda across PDx: from target product profile (TPP) and target product labeling (TPL) through Company Core Data Sheet (CCDS) stewardship and global implementation. This leader ensures that labeling is a core lever for product positioning and market access, translating clinical and CMC evidence into precise, defensible labeling language that differentiates our portfolio and enables compliant promotion and reimbursement. The role owns the end‑to‑end global labeling framework, governance, metrics, and systems, and leads high‑stakes agency negotiations to defend labeling and secure optimal indications and claims.

Key Responsibilities

• Strategic Labeling & Product Positioning
  • Lead the global labeling strategy for all PDx products (development and marketed), aligning with TPP/TPL and commercial strategies to e...