Global Regulatory Affairs, 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

Are you passionate about finding new pathways for approval of combination products? Do you have experience within clinical and non-clinical global regulatory affairs?

If so, now is your chance to join Ascendis Pharma as our new Associate Director.

Ascendis Pharmais a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease portfolio. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Associate Director to join our growing team. As a key member of the team, you will play a crucial role in strategic decisions and support regulatory approvals as well as development and life cycle management. This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the RA Clinical Strategy team in Denmark consisting of 10 colleagues, and report to Mette Schou-Hanssenwho is based in our Hellerup office, where you will also be based.

Your key responsibilities will be:

• Develop and execute global regulatory strategies in partnership with cross-functional teams to support product development and regulatory approvals.
• Lead the planning, preparation, review, and delivery of regulatory submissions, ensuring compliance with global regulatory requirements.
• Provide strategic regulatory guidance on clinical and nonclinical development activities, including risk assessment and issue management.
• Monitor and interpret evolving regulatory requirements, trends, and guidance, translating these into actionable recommendations for project teams.
• Represent Regulatory Affairs in cross-functional teams and health authority interactions, supporting negotiations and driving science-based regulatory decisions.
• Contribute to key development initiatives, including scientific advice, orphan drug designations, pediatric development plans, and change control assessments.
• Develop and maintain regulatory documentation and product information in accordance with applicable regulations.
• Drive continuous improvement of regulatory processes, promote knowledge sharing, and build strong relationships with internal and external stakeholders.

Qualifications and Skills:

You hold a relevant academic degree – preferably a master’s degree of science – and 10 years of experience within global regulatory affairs.

Furthermore, you have:

• Demonstrated expertise in global regulatory strategy, submissions, and health authority interactions.
• Solid understanding of clinical and nonclinical development requirements and applicable global regulations.
• Excellent communication, influencing, and stakeholder management skills.
• Ability to work independently, manage competing priorities, and deliver results in a complex global environment.

Key competencies:

You are a strong team player, analytical, and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

To succeed in this role, we also expect you to have a strategic mindset with strong problem-solving, decision-making, and risk management capabilities.

Travel: 15 days per year.

Office: Tuborg Boulevard 12, Hellerup

For more details about the position or the company, please contact Mette Schou-Hanssen, [e-mail].

You can learn more about Ascendis by visiting our website www.ascendispharma.com

Applications must be submitted in English and will be treated confidentially.