Global Head, Regulatory Affairs – Labeling; PDx

Position: Global Head, Regulatory Affairs – Labeling (PDx)
Overview

Job Description Summary  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.

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 enable optimal indications, claims, and competitive positioning.

Provide early, proactive feedback on clinical and CMC plans (Phase I–III and LCM) to shape endpoints, analyses, and evidence packages that unlock the best label and access outcomes.

Chair the Global Labeling Committee and Labeling Working Groups, driving crisp decisions, risk/benefit trade‑offs, and cross‑functional alignment.

CCDS Ownership & Global Implementation

Own CCDS creation, maintenance, and change control; ensure timely, consistent roll‑out into US, EU, China, Japan and other markets, with documented exceptions and transparent rationale.

Establish and track labeling KPIs (e.g., cycle times, first‑pass acceptance, variation close‑out, deviation rate) and drive continuous improvement across processes, templates, and training.

Agency Engagement & Negotiation

Serve as the principal labeling negotiator with FDA, EMA/NCAs, NMPA (China), PMDA (Japan) and other authorities; lead labeling‑focused meetings and written interactions to defend indication, population, claims, dosing, warnings, and promo‑relevant language.

Anticipate and mitigate labeling risks that lead to CRLs, REMS/PMR/PMC obligations, or restrictive language; escalate and resolve issues decisively.

Cross‑Functional Influence & Commercial Enablement

Partner with Market Access, Commercial, Medical, and Legal/Promo Review to ensure label‑to‑launch readiness and compliant promotional scope aligned to positioning and payer needs.

Translate complex regulatory concepts into clear executive narratives; influence senior stakeholders on evidence/label trade‑offs and go‑to‑market implications.

Operating Model, Systems & Compliance

Build and evolve the Global Labeling Center of Excellence, including governance, end‑to‑end processes, metrics, inspection readiness, and systems (e.g., Veeva RIM, ePI).

Ensure audit/inspection readiness and robust documentation across labeling decisions, deviations, and exceptions.

Ad Promo Oversight

Work with the Global Head RA, Ad Promo to provide the overarching leadership, alignment, and governance needed to ensure consistency between labeling, promotional claims, product positioning, market access needs, and global regulatory expectations.

Qualifications

Minimum 10 years of experience leading Global Labeling in a highly regulated pharmaceutical company, with a record of successful label negotiations and defense at FDA/EMA/NMPA/PMDA.

Demonstrated strategic influence across Clinical, CMC, Medical, Market Access, and Commercial to shape development and lifecycle plans toward best‑possible labeling and access.

Deep expertise in CCDS, core/product information, and global/local labeling execution (US/EU at minimum).

Exceptional negotiation and stakeholder management skills, internally and externally; proven ability to craft precise, defensible labeling language from clinical data.

Strong people leadership: building high‑performing teams, setting standards, and coaching labeling professionals and cross‑functional contributors.

Desired Characteristics

Hands‑on experience with Veeva RIM and labeling systems; understanding of ePI evolution.

Prior stewardship of a Global Labeling Committee/Working Group with measurable KPI…