Sr Regulatory Affairs Manager

Regulatory Affairs & Pharmacovigilance
Ørestaden, Denmark

Help shape regulatory strategy across EUCAN by driving approvals, lifecycle management and regulatory excellence that bring medicines to patients faster and more safely.

Your new role

As Senior Manager, Regulatory Affairs you will develop and drive regulatory activities across Region EUCAN, ensuring both internal and external compliance. You will create regional regulatory strategies and implementation plans, lead life‑cycle management (LCM) activities, identify opportunities for improvement, and represent the region in cross‑functional and global forums. Your work will connect affiliate perspectives with regional and global regulatory priorities to secure timely access and optimal labelling for our products.

Day‑to‑day your tasks will include:

• Create and execute regulatory strategy and implementation plans for Region EUCAN, collaborating closely with affiliates and Global Regulatory Affairs.


• Lead LCM activities across the region, coordinating cross‑functional stakeholders to deliver on lifecycle priorities and maintenance plans.


• Identify regulatory process or strategy improvements and drive pragmatic solutions to ensure best‑in‑class regulatory outcomes.


• Represent Region EUCAN in internal and external forums, acting as the regional contact for RA topics for affiliates, regional offices and global teams.


• Provide regulatory support and guidance to affiliates on submissions, labelling and compliance matters, ensuring alignment with regional and global approaches.


• Build and maintain strong stakeholder relationships with Regulatory, Medical, Clinical, Commercial, Supply and PV colleagues to support regulatory objectives.

Your new department

You will be part of the Regulatory Affairs & Pharmacovigilance department in Denmark. Our team ensures regulatory compliance and safeguards patient safety across the product lifecycle, working closely with global and regional colleagues to shape regulatory frameworks and support product availability.

Your skills & qualifications

To succeed in this role, you should:

• Hold a university degree in Pharmacy, Medicine or a related medical/scientific field.


• Have at least 5 years’ experience in Regulatory Affairs within the pharmaceutical industry, including experience working in international teams.


• Demonstrate leadership and a proven track record 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).


• Be detail‑focused, proactive, self‑motivated and able to navigate diverse organisational setups independently.


• Have advanced English language skills; additional language skills relevant to EUCAN are an advantage.

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.

Deadline

16th of February (Applications are reviewed on an ongoing basis)

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.