Global Regulatory Strategy Lead – Associate Director

Ascendis Pharma; Gentofte Kommune; On-site; DKK 1,000,000 - 1,300,000; Full time

Job summary

Ascendis Pharma, headquartered in Hellerup, Denmark, seeks an Associate Director to join Regulatory Affairs Clinical Strategy. You will lead global regulatory strategies, prepare and deliver submissions, and guide clinical/nonclinical development activities.

Travel ~15 days/yr with cross-functional, international teams to achieve regulatory approvals. Based in Denmark, you will manage interactions with health authorities and drive lifecycle management with strategic insight and leadership.

Qualifications

• Master’s degree in science and 10+ years in global regulatory affairs.
• Expertise in global regulatory strategy, submissions, and health authority interactions.
• Excellent communication, influencing, and stakeholder management skills.

Responsibilities

• Develop and execute global regulatory strategies in partnership with cross-functional teams to support product development and regulatory approvals.
• Lead planning, preparation, review, and delivery of regulatory submissions per global requirements.
• Provide strategic regulatory guidance on clinical and nonclinical development activities and risk management.
• Monitor evolving regulatory requirements and translate into actionable recommendations for project teams.
• Represent Regulatory Affairs in cross-functional teams and health authority interactions.

Skills

Global regulatory strategy

Regulatory submissions

Health authority interactions

Communication

Stakeholder management

Education

Master's degree in science

Job description

Ascendis Pharma, headquartered in Hellerup, Denmark, seeks an Associate Director to join Regulatory Affairs Clinical Strategy. You will lead global regulatory strategies, prepare and deliver submissions, and guide clinical/nonclinical development activities.

Travel ~15 days/yr with cross-functional, international teams to achieve regulatory approvals. Based in Denmark, you will manage interactions with health authorities and drive lifecycle management with strategic insight and leadership.