Global Labeling Strategy Director

Ascendis Pharma A/S

Princeton (NJ)

Hybrid

USD 220,000 - 240,000

Full time

4 days ago
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Benefits offered by this job

401(k) plan with company match
Medical, dental, and vision plans
Life and AD&D insurance
Disability benefits
Pet Insurance

Job summary

Ascendis Pharma is seeking a strategic Director, Head of Global Labeling to lead the worldwide labeling program for our endocrinology portfolio. You will influence governance bodies, shape development labeling strategies, and collaborate across Legal, Clinical Development, Medical Affairs, and Market Access to drive regulatory excellence.

The role requires deep global labeling expertise, strong leadership, and the ability to operate in a complex matrix.

Qualifications

  • 15+ years in pharmaceutical industry experience.
  • At least 10 years in global regulatory affairs with labeling focus.
  • Minimum 5 years of people leadership and matrix collaboration.
  • Deep expertise in product labeling strategy and compliance.
  • Experience establishing and evolving Global Labeling functions.

Responsibilities

  • Lead the Global Labeling function and portfolio for endocrinology products.
  • Develop a collaborative global labeling team and operating model.
  • Define global labeling operations aligned with business objectives.
  • Provide guidance to governance bodies and cross-functional stakeholders.
  • Own labeling processes and governance including Global Labeling Committee.
  • Ensure timely, compliant implementation of labeling changes.
  • Lead labeling audits, inspections, and cross-functional reviews.

Skills

Global labeling strategy
Regulatory leadership
Stakeholder influence
Strategic thinking
Cross-functional collaboration
Regulatory information systems
Communication

Education

Bachelor's degree

Tools

Veeva Vault

Job description

Ascendis Pharma is seeking a strategic Director, Head of Global Labeling to lead the worldwide labeling program for our endocrinology portfolio. You will influence governance bodies, shape development labeling strategies, and collaborate across Legal, Clinical Development, Medical Affairs, and Market Access to drive regulatory excellence.

The role requires deep global labeling expertise, strong leadership, and the ability to operate in a complex matrix.

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