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Salary: USD 220,000 - 240,000 / annual
Ascendis Pharma, a dynamic global biopharmaceutical company with locations in Denmark, Europe, and the United States, is seeking a Director, Head of Global Labeling to lead its global labeling function and strategy. The company advances programs in Endocrinology Rare Disease and Oncology using its proprietary TransCon® drug development platform.
In this role, you will sit on the Global Regulatory Leadership Team as the strategic leader for global labeling. You will provide expert guidance to governance bodies, shape development labeling strategies, and drive excellence across the organization. This highly visible position requires a collaborative leader who thrives in complex global environments, excels at cross-functional influence, and is passionate about advancing regulatory labeling strategy and delivering business impact.
Key responsibilities include:
- Leading the Global Labeling function and overseeing the worldwide labeling portfolio for Ascendis endocrinology products
- Building and developing a collaborative global team and operating model that delivers scientifically sound, regulatory-compliant core and local labeling while supporting portfolio growth
- Defining and driving global labeling strategies and operations that support business objectives, optimize product benefit-risk communication, and meet regulatory and clinical requirements
- Providing strategic and operational labeling leadership and expert guidance to governance bodies (e.g., Global Labeling Committee), cross-functional stakeholders, local affiliates, and external partners
- Owning and continuously improving labeling processes and governance, including leadership of the Global Labeling Committee and oversight of core labeling documents
- Ensuring timely and compliant implementation of labeling changes globally, including communication and rollout of safety-related updates
- Leading labeling-related audits, inspections, and governance activities, and representing Global Labeling on cross-functional review boards
You will collaborate closely with colleagues across Global Regulatory Affairs, Global Patient Safety, Legal, Regulatory Advertising & Promotion, Clinical Development, Commercial Development, Medical Affairs, Market Access, and others to ensure labeling strategies align with both requirements and organizational priorities.
Travel: Up to 15% domestically and internationally.
Requirements:
- Bachelor's degree from an accredited university in a relevant field; professional-level English proficiency
- 10+ years of pharmaceutical industry experience, including minimum 7 years in global regulatory affairs with extensive experience in global labeling strategy and operations, and at least 5 years of people leadership
- Deep expertise in global labeling and regulatory requirements, including product labeling strategy, risk minimization, and regulatory compliance across global markets; demonstrated experience establishing, leading, and continuously evolving a Global Labeling function and capability
- Demonstrated success leading teams and influencing stakeholders in complex, matrixed, and cross-cultural environments
- Strong strategic, communication, and organizational skills, with ability to drive decisions, build effective relationships, and communicate complex scientific and regulatory concepts to diverse audiences
- Strong digital and systems acumen, with experience using regulatory information management and labeling systems; experience with Veeva Vault preferred
- Passion for advancing innovative therapies that address unmet medical needs for patients with Rare Endocrine Diseases
- Ability to balance strategic thinking with hands-on execution
- Demonstrated ability to navigate uncertainty and adapt quickly to changing priorities in a global matrix organization
- Proven track record delivering results in dynamic, fast-paced settings
