Director, Head of Global Labeling

About the role

Ascendis Pharma, a global biopharmaceutical company focused on endocrinology rare disease and oncology, is seeking a Director, Head of Global Labeling. As a member of the Global Regulatory Leadership Team, you will lead the global labeling function and its worldwide portfolio for Ascendis endocrinology products, advise governance bodies such as the Global Labeling Committee, and work with Global Regulatory Affairs, Patient Safety, Legal, Clinical Development, Commercial Development, Medical Affairs and Market Access.

Key responsibilities

• Build and develop a collaborative global labeling team and operating model that delivers scientifically sound, regulatory-compliant core and local labeling.
• Define and drive global labeling operations that support business objectives, optimize benefit-risk communication and meet regulatory and clinical requirements.
• Provide strategic and operational labeling leadership to governance bodies, cross-functional stakeholders, local affiliates and external partners.
• Own and continuously improve labeling processes and governance, including the Global Labeling Committee and core labeling documents.
• Ensure timely and compliant implementation of labeling changes globally.
• Lead labeling-related audits, inspections and governance activities, and represent Global Labeling on cross-functional review boards.

Required profile

• Bachelor's degree from an accredited university and professional English proficiency.
• 15+ years of pharmaceutical industry experience, including at least 10 years in global regulatory affairs and global labeling strategy and operations.
• At least 5 years of people leadership.
• Demonstrated success leading teams and influencing stakeholders in complex, matrixed, cross-cultural environments.
• Ability to travel up to 15% of the time domestically and internationally.

Required skills

• Deep expertise in global labeling and regulatory requirements, including product labeling strategy, risk minimization and regulatory compliance.
• Experience establishing, leading and evolving a Global Labeling function.
• Experience with regulatory information management and labeling systems; Veeva Vault experience preferred.

What we offer

• Estimated salary range of $220-$240K, depending on experience, qualifications and location.
• Possible discretionary annual bonus, stock-based long-term incentives and paid time off.
• 401(k) with company match, medical, dental and vision plans, life and AD&D insurance, disability benefits, pet and legal insurance, EAP, employee discounts, HSA and flexible spending accounts.
• Hybrid role based in Princeton, NJ, Palo Alto, CA or Copenhagen corporate offices.