Associate Director, Global Regulatory Affairs (Hellerup)

Job summary

This role involves developing and executing global regulatory strategies for combination products within a biopharmaceutical context. The Associate Director will play a key role in regulatory approvals and lifecycle management, working closely with cross-functional teams.

Qualifications

• Relevant academic degree, preferably a Master’s in Science.
• 10 years of experience in global regulatory affairs.
• Expertise in regulatory strategy, submissions, and health authority interactions.
• Strong understanding of clinical and nonclinical development requirements.
• Excellent communication and stakeholder management skills.

Responsibilities

• Develop and implement regulatory strategies to support product development and approvals.
• Lead the preparation and delivery of regulatory submissions, ensuring compliance with global regulations.
• Provide strategic guidance on clinical and nonclinical activities, including risk assessment.
• Monitor regulatory trends and translate them into actionable recommendations.
• Represent Regulatory Affairs in cross-functional teams and health authority interactions.
• Contribute to development initiatives like orphan drug designations and pediatric plans.
• Maintain regulatory documentation in accordance with applicable regulations.
• Drive improvements in regulatory processes and foster strong stakeholder relationships.

Skills

• Strong analytical and problem-solving skills.
• Ability to work independently and manage competing priorities.
• Team player with an entrepreneurial mindset.

Education

• Master’s degree in a relevant field preferred.

Tools

• Familiarity with regulatory submission tools and documentation practices.