The roleAs 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 and 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.
You will - Lead the Global Labeling function and oversee the worldwide labeling portfolio for Ascendis endocrinology products.
- Build and develop a collaborative global team and operating model that delivers scientifically sound, regulatory-compliant core and local labeling while supporting portfolio growth.
- Define and drive global labeling strategies and 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 (eg: 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, including the communication and rollout of safety-related updates.
- Lead labeling-related audits, inspections, and governance activities, and represent Global Labeling on cross-functional review boards as needed.
RequirementsYour professional qualifications - You hold a relevant academic bachelor's degree from an accredited university and are proficient in English at a professional level.
You have- 10+ years of pharmaceutical industry experience, including a minimum of 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, 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.
As a person, you have/are- 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
Travel: Ability to travel up to 15% of the time domestically and internationally
Office Location: This is a hybrid role operating out of our Princeton, NJ office
The estimated salary range for this position is $220 - $240K. Actual salary determination is dependent on a variety of factors, some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
Benefits- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of Pet Insurance and Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Saving Account (HSA)
- Flexible Spending Accounts
- Various incentive compensation plans
- Accident, Critical Illness, and Hospital Indemnity Insurance
- Mental Health resources
- Paid leave benefits for new parents
