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Ascendis Pharma, a global biopharmaceutical company, is seeking an Associate Director for Global Regulatory Affairs to join its RA Clinical Strategy team in Hellerup, Denmark. The role reports to the team lead and involves strategic regulatory leadership for combination products and innovative therapies using the company's TransCon® technology platform.
Key responsibilities include developing and executing global regulatory strategies in partnership with cross-functional teams to support product development and regulatory approvals. You will lead the planning, preparation, review, and delivery of regulatory submissions while ensuring compliance with global regulatory requirements. The role requires providing strategic regulatory guidance on clinical and nonclinical development activities, including risk assessment and issue management.
You will monitor and interpret evolving regulatory requirements and trends, translating these into actionable recommendations for project teams. The position involves representing Regulatory Affairs in cross-functional teams and health authority interactions, supporting negotiations and driving science-based regulatory decisions. You will contribute to key development initiatives including scientific advice, orphan drug designations, pediatric development plans, and change control assessments.
Additional responsibilities include developing and maintaining regulatory documentation and product information in accordance with applicable regulations, and driving continuous improvement of regulatory processes while building strong relationships with internal and external stakeholders.
The ideal candidate holds a master's degree in a relevant scientific field and brings 10+ years of experience in global regulatory affairs. You should demonstrate expertise in global regulatory strategy, submissions, and health authority interactions, with a solid understanding of clinical and nonclinical development requirements and applicable global regulations. Excellent communication, influencing, and stakeholder management skills are essential, along with the ability to work independently, manage competing priorities, and deliver results in a complex global environment.
You are a strong team player with an analytical mindset and can-do attitude. An entrepreneurial mindset and ability to thrive in an informal, open environment where innovation and change are key are important. Strategic thinking, strong problem-solving, decision-making, and risk management capabilities are required. Travel is approximately 15 days per year.
