Director, Head of Global Labeling - Job ID: 2053

Ascendis Pharma•Palo Alto, CA

4d•$220,000 - $240,000•Hybrid

About The Position

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. Are you an experienced and strategic regulatory affairs leader looking for an opportunity to shape global labeling strategy and optimize operational execution? Ascendis is seeking a collaborative and influential regulatory leader to shape and advance our global labeling strategy. As Director, Head of Global Labeling, you will sit on the Global Regulatory Leadership Team as the strategic leader for the Ascendis global labeling function. In this capacity you will provide expert guidance to governance bodies, shaping development labeling strategies, and driving excellence across the organization. This highly visible role requires a collaborative leader who thrives in a complex global environment, excels at influencing across functions, and is passionate about advancing regulatory labeling strategy, and delivering business impact. 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. If you are energized by strategic leadership, complex regulatory challenges, and the opportunity to make a meaningful impact on global labeling development and commercialization, we encourage you to explore this exciting opportunity.

Requirements

Hold a relevant academic bachelor’s degree from an accredited university and are proficient in English at a professional level.
15+ years of pharmaceutical industry experience, including a minimum of 10 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, with 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 the 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 is preferred.
A passion for advancing innovative therapies that address unmet medical needs for patients struggling with Rare Endocrine Diseases
Comfortable balancing 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 where clarity evolves over time
Ability to travel up to 15% of the time domestically and internationally

Nice To Haves

Experience with Veeva Vault is preferred.

Responsibilities

Lead the Global Labeling function and oversee the worldwide labeling portfolio for Ascendis endocrinology products.
Build and develop a collaborative global labeling team and operating model that delivers scientifically sound, regulatory-compliant core and local labeling while supporting portfolio growth.
Define and drive global labeling operations that support business objectives, optimize product benefit-risk communication, and meet regulatory and clinical requirements.
Provide strategic and operational labeling leadership and expert guidance to governance bodies (e.g.: Global Labeling Committee), cross-functional stakeholders, local affiliates, and external partners.
Own and continuously improve labeling processes and governance, including leadership of the Global Labeling Committee and oversight of 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 as needed.