Associate Director Regulatory Affairs

Category:  Reg Affairs & Safety Pharmacovigilance
Location: 

Søborg, Capital Region of Denmark, DK

   

Are you passionate about leading teams and supporting regulatory strategies? Do you excel in working with a wide range of stakeholders to ensure compliance and quality? Join us and help shaping regulatory strategies in Regulatory Affairs Semaglutide (Therapeutic Area) by driving approvals, lifecycle management and regulatory excellence that bring medicines to patients faster and more safely.

Your new role

As Associate Director in Regulatory Affairs Semaglutide, you will lead a team of specialists and regulatory professionals. You will report to the Director and be a part of the leadership team. You will be responsible for providing leadership, coaching and direction for the team as well as supporting regulatory strategies, label development, health authority interactions, and high-quality regulatory submissions which include initial marketing authorisation applications and clinical trial applications.

 

The role operates in a global regulatory environment, requiring close collaboration with HQ functions, affiliates and regions, both global and local health authorities, and external partners. You will act with an enterprise mindset, balancing strategic direction with operational excellence.


Day‑to‑day tasks will include:

  • Provide leadership, coaching, and direction to ensure high performance, engagement, and development of the team in accordance with Novo Nordisk Way
  • Align team capabilities with business ambitions and evolving regulatory and stakeholder expectations
  • Actively contribute to the area leadership team and broader organisational priorities
  • Manage complex, overlapping timelines and priorities in a dynamic environment
  • Drive regulatory strategy and execution plans across assigned therapy areas and projects
  • Oversee regulatory submissions, labelling activities, and compliance matters in alignment with regional and global approaches
  • Identify opportunities to improve regulatory processes and strategies, driving pragmatic, best‑in‑class solutions
  • Build and maintain strong relationships with internal and external stakeholders to support regulatory objectives
  • Ensuring the quality of work processes in the department/team and compliance with internal and external requirements

 


Your Skills & Qualifications
To succeed in this role, you have:

  • A university degree (e.g. Pharmacy, Medicine or a related field); advanced degree (MSc and/or PhD) preferred
  • + 8 years of experience in Regulatory Affairs within the pharmaceutical industry, including experience working in international teams
  • A minimum of 3 years of leadership experience, with a proven track record of managing regional regulatory activities and ensuring compliance with regulatory requirements
  • Show strong business acumen, agility and a solutions‑oriented mindset with excellent stakeholder management and communication skills (upwards and downwards)
  • Ability to navigate complex organisational set-ups with independence and accountability
  • An enterprise mindset, taking decisions for the greater benefit of Novo Nordisk
  • Be fluent in written and spoken English

 

On a personal level, you lead with authenticity and integrity. You motivate and empower others, provide constructive feedback, and build trust through clear communication and collaboration. You thrive in a fast‑paced environment, set ambitious goals, and consistently deliver on commitments.

 

 

About the department

The Regulatory Affairs Semaglutide department is responsible for defining and driving regulatory strategies for our marketed semaglutide products, which are transforming and improving the lives of millions of people worldwide. The team oversees all regulatory activities with focus on the clinical aspects and labelling, including health authority interactions to support and clarify regulatory strategies, and providing regulatory expertise and tactics to the projects and product development plans. The position is based in Søborg, Denmark.

 

 

Working at Novo Nordisk
At Novo Nordisk we aspire to be the best company for the world. We value diverse perspectives and are committed to an inclusive culture that celebrates differences. Join a collaborative, dynamic team where your regulatory expertise will help safeguard patient safety and improve access to life‑changing medicines.

 

Contact

For further information please contact Trine Kruse at trik@novonordisk.com or +45 3448 1008, or get to know us better by visiting www.novonordisk.com/careers.

 

Deadline
10. April 2026


We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.