Global Labeling Leader: Regulatory Strategy & Operations

Ascendis Pharma; Palo Alto (CA); Hybrid; USD 220,000 - 240,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, and vision plans

AD&D insurance

Disability benefits

Pet Insurance

Employee Assistance Program

Professional Development

Health Savings Account (HSA)

Flexible Spending Accounts (FSA)

Incentive compensation plans

Mental Health resources

Paid leave benefits for new parents

Job summary

Ascendis Pharma is seeking a Director, Head of Global Labeling to lead the worldwide labeling strategy for its endocrinology portfolio. This high-visibility role reports to the Global Regulatory Leadership Team and requires collaboration across Regulatory Affairs, Legal, Clinical Development, Medical Affairs, and Commercial Development to ensure compliant, scientifically sound labeling.

You will guide governance bodies, drive development labeling strategies, and optimize operations in a complex

Qualifications

• 15+ years in pharmaceutical industry experience.
• Minimum 10 years in global regulatory affairs with global labeling
• At least 5 years of people leadership experience
• Deep expertise in global labeling requirements and regulatory compliance
• Experience leading a Global Labeling function and influencing stakeholders across a matrix organization

Responsibilities

• Lead the Global Labeling function and portfolio for Ascendis endocrinology products.
• Build a collaborative global labeling team and operating model.
• Define and drive global labeling operations aligning with business objectives.
• Provide strategic guidance to governance bodies and cross-functional partners.
• Own labeling processes and governance, including Global Labeling Committee leadership.
• Ensure timely, compliant global labeling changes and governance.
• Lead labeling audits, inspections, and cross-functional review boards.

Skills

Global regulatory affairs

Global labeling

Leadership

Strategic thinking

Regulatory systems

Education

Bachelor's degree

Tools

Veeva Vault

Job description

Ascendis Pharma is seeking a Director, Head of Global Labeling to lead the worldwide labeling strategy for its endocrinology portfolio. This high-visibility role reports to the Global Regulatory Leadership Team and requires collaboration across Regulatory Affairs, Legal, Clinical Development, Medical Affairs, and Commercial Development to ensure compliant, scientifically sound labeling.

You will guide governance bodies, drive development labeling strategies, and optimize operations in a complex