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Novo Nordisk A/S · Life sciences

Regulatory Affairs Specialist and Area Process Manager

Novo Nordisk A/S Søborg, DK Posted Aug 14, 2026
Location
Søborg, DK
Workplace
On-site / per employer
Posted
Aug 14, 2026

About this role

RA Rare Bleeding & Haematorenal Søborg, Denmark Do you want to help shape the future of regulatory submissions and accelerate patient access to life-changing medicines? Join us as our next Area Process Manager and become a key driver of Novo Nordisk’s submission transformation journey. In this role, you will have the opportunity to influence how we work across Regulatory Affairs, strengthening submission and registration processes that support efficient approvals and launches around the world.

By combining strategic thinking, process excellence and strong stakeholder engagement, you will help create lasting impact for both our organization and the patients we serve. Your new role As Area Process Manager in Regulatory Affairs, you will have a unique opportunity to shape and elevate the submission and registration landscape across the organization, helping bring innovative treatments to patients faster through efficient and high-performing processes. You will be a key player in our submission transformation journey, championing continuous improvement, collaboration and operational excellence.

Your main responsibilities will include: Ensuring efficient and well-performing submission and registration processes across the organization. Chairing the Area Process Group, participating in the Corporate Process Group and partnering with other relevant forums, such as management groups. Coordinating process activities within your own area.

Acting as an ambassador for the process and supporting RA clinical colleagues by ensuring that compliance and performance issues, as well as improvement opportunities, are communicated to the Process Owner. Acting as Content Responsible or reviewer of unit content, and coordinating and consolidating the review of corporate content in the area. Your new department You will join Regulatory Affairs in the Regulatory, Quality and Clinical Reporting organization at Novo Nordisk.

Regulatory Affairs is responsible for defining and driving regulatory strategies for Novo Nordisk’s diverse product portfolios, from early research through development and for marketed products. We work as an integrated part of the global research and development organization and play a key role in cross-functional teams. We are responsible for regulatory strategy and provide regulatory expertise and tactics for product development plans.

We drive label development, health authority interactions and global submission strategies, working in strong collaboration with affiliates and global stakeholders across regulatory teams. In this role, you can expect frequent interaction with leaders across Regulatory Affairs, including Headquarters, the US and International Operations. You will influence how we work, accelerate delivery and contribute to bringing important medicines to patients around the world.

Your skills and qualifications We are looking for someone who is comfortable speaking their mind, enjoys solving challenging problems and has strong personal drive, with the ability to stay motivated under pressure. You bring professional and personal impact, reflected in your willingness to take initiative, and you are committed to taking responsibility for your own learning. To be a competitive candidate, you should: Hold a Master’s degree or PhD in science, pharmaceutical sciences, health sciences or a related discipline, combined with 7 to 8 years of experience in Regulatory Affairs or drug development.

Bring a passion for process excellence, with a strong end-to-end understanding of regulatory processes and a commitment to compliant, efficient implementation and execution. Demonstrate leadership and facilitation skills, with the ability to drive collaboration, chair cross-functional forums and influence outcomes without formal authority. Excel in stakeholder management and communication, building alignment across functions and engaging effectively with colleagues at all organisational levels.

Have strong execution and coordination capabilities, turning strategic decisions into tangible actions and ensuring successful implementation. Embody a growth mindset, bringing a positive, self-motivated and change-oriented approach, with a willingness to experiment, drive continuous improvement and view challenges as opportunities for innovation and learning. 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 742,600.00 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 Contact For further information about the position, please contact Trine Cecilia Thy Gregersen at +45 34480864 or Jane Møll Pedersen at +45 30753759. Deadline 30 August 2026. 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.

Originally posted by Novo Nordisk A/S. View original posting

Regulatory Affairs Specialist and Area Process Manager at Novo Nordisk A/S | BioCareerAI