Regulatory Affairs Specialist

Regulatory Affairs Specialist  

Shape the regulatory future of an expanding portfolio – from early-stage molecules to global market approvals – and see your strategic thinking translated into treatments that reach patients worldwide.

Your new role

As a Regulatory Affairs CMC Specialist, you will take the lead on regulatory CMC strategy across Novo Nordisk's growing portfolio in Rare Disease, Cardiovascular Disease and Diabetes. Working across early and late-stage development projects, you will be the voice of Regulatory Affairs CMC – translating deep pharmaceutical knowledge into robust global regulatory pathways that secure timely approvals.

This is a role with significant exposure: you will lead projects without direct line management responsibility, navigating complex stakeholder landscapes and driving strategic direction across multidisciplinary teams.

Your responsibilities will include:

- Leading and driving strategic regulatory CMC activities across early and late-stage development projects to ensure timely global regulatory approvals and compliance

- Developing robust global regulatory CMC strategies based on current legislation, regulatory intelligence and scientific rationale for drug substance and drug product

- Providing scientific and strategic CMC input to cross-functional project teams, acting as the regulatory CMC authority in submissions worldwide

- Managing extensive stakeholder relationships across functions, sites and geographies to align on regulatory approaches and resolve complex challenges

- Identifying and improving regulatory CMC practices, processes and approaches to strengthen documentation quality and strategic consistency

- Contributing to the continued evolution of how we work as the portfolio grows and new CMC solutions are developed for increasingly complex manufacturing processes

Your new department

In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.

Within R&D, you will join Regulatory Affairs CMC & Device – a team that makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals across all global markets. The RA CMC Development area consists of over 50 highly skilled colleagues with diverse backgrounds, involved in every regulatory CMC aspect of our Rare Disease, Cardiovascular Disease and Diabetes portfolios. With Novo Nordisk's product portfolio growing rapidly and new projects continuously coming through the pipeline, this is an exciting time to join a team that is expanding to meet the challenge.

Your skills & qualifications

We are looking for an experienced regulatory CMC professional who thrives on strategic complexity, brings strong project leadership capabilities, and is energised by the prospect of shaping a growing portfolio.

You will bring:

- A Master's degree and/or PhD in a relevant scientific field

- At least 8 years of relevant experience within Regulatory Affairs CMC in the pharmaceutical industry

- Proven RA CMC experience working with drug substance and drug product across early and late-stage development

- Strong project management capabilities with the ability to lead cross-functional initiatives, set strategic direction and drive delivery without direct line authority

- Excellent stakeholder management skills and the confidence to navigate uncertainty, influence across functions, and communicate effectively in a global, multidisciplinary setting

- High proficiency in written and spoken English

- A digital mindset and openness to leveraging new tools and ways of working is a plus

We expect you to be someone with a can-do attitude who finds ways forward when the path is unclear. You are a dedicated team player who builds strong working relationships, gains recognition through proactiveness and integrity, and thrives in the reality of international collaboration across time zones and cultures.

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

 At Novo Nordisk, you'll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.  

 Salary: For this role, the Annual Base Salary ranges from 742,600 to 1,091,600.00 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

Deadline

Please submit your application by 14 August 2025. Applications are reviewed on an ongoing basis.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. All applications must be submitted via the official application channel. 

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.