Regulatory Affairs CMC Specialist

Are you passionate about CMC drug development and regulatory strategy within a leading international organization? Do you want to play a key role in shaping global regulatory pathways for medicines addressing high unmet medical needs? If so, this could be your next life‑changing career move at Novo Nordisk.

Your new role

As a Regulatory Affairs CMC Specialist, you will support selected products in the Novo Nordisk portfolio, focusing on late‑stage development and life‑cycle management submissions across global markets. Acting as the voice of Regulatory Affairs CMC, you will provide scientific and strategic input to secure regulatory approvals and ensure compliance with evolving global regulations.

In this role, you will:

• Lead and drive strategic regulatory CMC activities to ensure timely approvals and compliance
• Translate pharmaceutical operations knowledge into robust global regulatory CMC strategies
• Apply CMC regulatory intelligence to strengthen submissions and regulatory pathways
• Plan, coordinate and review regulatory documentation, including submission modules and responses to health authority questions
• Contribute to continuous improvement of regulatory CMC practices, processes and documentation

Your new department

You will join Regulatory Affairs CMC & Device, a global organization of more than 200 dedicated professionals working across multiple regions. The department plays a critical role in making medicines available worldwide by ensuring efficient, high‑quality regulatory submissions and approvals. As Novo Nordisk’s product portfolio continues to expand, the team develops diverse and innovative CMC solutions for increasingly complex manufacturing processes.
The position can be based in Søborg, Denmark or Bangalore, India, offering exposure to global projects and close collaboration across cultures and time zones.

Your skills and qualifications

You bring a strong scientific and technical foundation, combined with deep regulatory or pharmaceutical operations experience.

To succeed in this role, you are expected to have:

• A Master’s degree and/or PhD in a relevant scientific field
• Extensive experience from the pharmaceutical industry and/or a health authority
• At least 8 years of relevant experience within Regulatory Affairs CMC or a closely related area; experience with drug‑device combination products is an advantage
• Strong project management skills and the ability to navigate complex stakeholder landscapes
• Excellent English communication skills, both written and spoken, and the ability to work effectively in multidisciplinary, international teams

You are recognised for your proactive, can‑do mindset and your ability to thrive in uncertainty, helping teams find clear paths forward while acting as a professional role model.

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Salary: For this role, the Annual Base Salary for employee based in Denmark ranges from 742,600 to 1,091,600 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short‑term and/or long‑term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here.

Contact:
For further information about the position, please contact Milos Marinkovic at mmvc@novonordisk.com.

Deadline:
20 May 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.