Senior Director, Regulatory Affairs for CMC and Lifecycle Management

We are seeking a Senior Director in Regulatory Affairs for CMC and Lifecycle Management to shape the regulatory future of our life-saving medicines and lead the teams to ensure millions of patients worldwide have access to our innovative treatments. Whether your leadership background is in the pharmaceutical industry or you have built a world-class career in FMCG managing complex regulatory compliance and product quality standards, we invite you to bring your expertise to a role that impacts global health. If this sounds like you, read on and apply today!

Your new role

Based in Soborg, Denmark, this role reports directly to the Vice President. As Senior Director of Regulatory Affairs for CMC and Lifecycle Management, you will lead a global organization spanning four departments. You will be responsible for the "Chemistry, Manufacturing, and Controls" (CMC) regulatory activities across our entire product portfolio. Essentially, you ensure that how we make our products (scale, optimize, maintain), and any changes we make to that process, always meets the strict legal and quality standards required by governments worldwide.

Your responsibilities will include:

• Leading Regulatory Strategy: Overseeing all activities that maintain the "license to operate" for our products globally. Ensuring manufacturing stays compliant as it scales through seamless regulatory maintenance of registered products worldwide at Novo Nordisk manufacturing facilities and contract manufacturing organizations.

• Driving Approval Strategies: Developing plans to get the green light from authorities for major investments, such as new manufacturing sites or facility expansions.
• Cross-Functional Collaboration: Partnering with supply chain and manufacturing teams to secure and maintain operating licenses for all facilities.
• Global Team Leadership: Building and leading high-performing teams across Denmark, India, and the USA, focusing on talent development and succession planning.
• Complex Negotiations: Managing high-stakes discussions with major regulatory bodies (like the FDA, EMA and PMDA) to secure the best pathways for product approvals.
• Portfolio Oversight: Ensuring a seamless transition as products move from the experimental phase into large-scale, long-term manufacturing.

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. Within R&D, you’ll join the Regulatory, Quality, and Clinical Reporting area and become a member of the Regulatory Affairs CMC & Device Leadership Team. Your organization spans three continents and plays a critical role in enabling our transformation journey. You’ll work at the intersection of regulatory science, manufacturing excellence, and commercial strategy, ensuring our expanding portfolio reaches patients without delay.

Your skills & qualifications

We are seeking an exceptional leader who thrives in complex, global environments. While pharmaceutical experience is a plus, we highly value leaders from other highly regulated sectors, such as FMCG, who understand the rigor of maintaining product compliance across diverse international markets.

To succeed in this role, you bring:

• Educational Background: A Master’s degree in Life Sciences, Engineering, or a related field.
• Extensive Experience: Minimum 15 years of progressive experience, including significant expertise in regulatory affairs or compliance management within a global manufacturing context.
• Regulatory Savvy: Deep knowledge of international regulatory requirements (FDA, EMA, PMDA, China NMPA) and experience negotiating directly with major health or safety authorities.
• Strategic Execution: A strong track record of executing strategies for manufacturing facilities, product transfers, or lifecycle management.
• Agility: The political and strategic agility to navigate complex organizational dynamics while staying focused on business outcomes.
• Leadership Excellence: Demonstrated success leading global teams and complex matrix organizations, with a proven ability to drive results at senior executive levels.
• Stakeholder Management: Exceptional ability to influence senior leadership and build consensus across different functions and geographies.

• Talent Development:  Proven ability to develop talent, build succession pipelines, and create high-performing, engaged teams across 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

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. We offer a culture of diverse thinking, shared purpose, and mutual respect.

Deadline

Tuesday, 5 May 2026. 

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Applications are continuously assessed throughout the recruitment process.

For further information, please contact Jacob Dahl Nielsen at JCDN@novonordisk.com or visit www.novonordisk.com/careers.

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.