Global Head, Regulatory Affairs – Labeling (PDx)

• 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 companies, 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 improvement.

• Advanced degree in life sciences or pharmacy; Market Access literacy to connect label language to reimbursement and promo scope.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.