Global Head, Regulatory Affairs – Labeling

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the global labeling strategy for all PDx products, both in development and those already marketed.

• Offer early and proactive insights on clinical and CMC plans (Phase I–III and LCM) to influence endpoints, analyses, and evidence packages that facilitate optimal labeling and access results.

• Chair the Global Labeling Committee and Labeling Working Groups, ensuring clear decisions, risk/benefit evaluations, and alignment across functions.

• Manage the creation, maintenance, and change control of CCDS; guarantee timely and consistent implementation in the US, EU, China, Japan, and other regions, with documented exceptions and transparent justifications.

• Set and monitor labeling KPIs (such as cycle times, first-pass acceptance rates, variation close-out, and deviation rates) and promote continuous improvement in processes, templates, and training.

• Act as the primary labeling negotiator with FDA, EMA/NCAs, NMPA (China), and PMDA (Japan), leading discussions and written communications to defend indications, populations, claims, dosing, warnings, and promotional language.

• Proactively identify and address labeling risks that may result in CRLs, REMS/PMR/PMC obligations, or restrictive language; escalate and resolve issues decisively.

• Collaborate with Market Access, Commercial, Medical, and Legal/Promo Review teams to ensure readiness for label-to-launch and compliance with promotional scope aligned to positioning and payer requirements.

• Simplify complex regulatory concepts into clear narratives for executives; persuade senior stakeholders regarding evidence/label trade-offs and market entry implications.

• Develop and enhance the Global Labeling Center of Excellence, including governance, comprehensive processes, metrics, inspection readiness, and systems (such as Veeva RIM, ePI).

• Maintain audit/inspection readiness and ensure thorough documentation of labeling decisions, deviations, and exceptions.

• Collaborate with the Global Head RA, Ad Promo to provide the necessary leadership, alignment, and governance to ensure consistency among labeling, promotional claims, product positioning, market access requirements, and global regulatory expectations.

⛳️ Requirements

• At least 10 years of experience in leading Global Labeling within highly regulated pharmaceutical companies.

• Proven strategic influence across Clinical, CMC, Medical, Market Access, and Commercial sectors to guide development and lifecycle plans toward optimal labeling and access.

• Extensive knowledge in CCDS, core/product information, and the execution of global/local labeling (US/EU at a minimum).

• Outstanding negotiation and stakeholder management abilities, both internally and externally; demonstrated capability to create precise, defensible labeling language based on clinical data.

• Strong leadership skills: fostering high-performing teams, establishing standards, and mentoring labeling professionals and cross-functional contributors.

🏝️ Benefits

• Medical coverage

• Dental coverage

• Vision coverage

• Paid time off

• A 401(k) plan with opportunities for employee and company contributions

• Life, disability, and accident insurance

• Tuition reimbursement