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.
The role
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.
You will
- 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.
Requirements
Your 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
- 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.
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, Palo Alto, CA office or Copenhagen Corporate 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
Ascendis Pharma is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees.
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.