Regulatory Affairs Specialist

Novo Nordisk; Gladsaxe Kommune; On-site; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk in Denmark is seeking a Regulatory Affairs Specialist to develop regulatory strategies and drive their execution across the GLP-1 portfolio, cooperating with the Global Regulatory Lead and cross‑functional teams. You will lead regulatory submissions, liaise with Health Authorities and affiliates, coach colleagues, and contribute to continuous regulatory excellence, with a focus on timely, high‑quality deliverables in a global environment.

The role requires a Master’s or Ph.D.

Qualifications

• Master’s degree or Ph.D. in science, pharmaceutical or health science
• 7–8 years of experience in Regulatory Affairs or related area in drug development
• Knowledge of global regulatory strategies and regulatory documentation requirements
• Fluent English (written and spoken)
• Proactive, with project management skills and flexibility
• Strong communication across organizational levels and self-motivation

Responsibilities

• Contribute regulatory expertise to global development strategies and provide strategic recommendations
• Lead regulatory submission activities including briefing packages and global submissions
• Coordinate with affiliates and international stakeholders to align local and global regulatory strategies
• Coach and guide regulatory professionals and contribute to capability development
• Participate in department initiatives to strengthen regulatory excellence and operational effectiveness

Skills

Regulatory strategy

Project management

Global submissions

Stakeholder collaboration

English fluency

Education

Master’s degree or Ph.D. in science/health science

Job description

Do you want to be part of an exciting environment where engaged people are committed to optimize Novo Nordisk’s medicines across the globe? If yes, join us! We are looking for a Regulatory Specialist!

Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.

The position

As Regulatory Affairs Specialist, you will be responsible for developing regulatory strategies and lead their execution via interaction with cross-functional teams. You will lead, drive and coordinate several regulatory activities related to the Novo Nordisk GLP-1 portfolio. This will entail close collaboration with the Global Regulatory Lead.

Your Responsibilities Will Include

• Contributing regulatory expertise to global development strategies by identifying opportunities, assessing risks, and providing strategic recommendations
• Leading key regulatory submission activities, including briefing packages for interactions with Health Authorities, clinical trial applications, and global regulatory submission initiatives ensuring high-quality and timely deliverables
• Collaborating with affiliates and international stakeholders to ensure alignment between local and global regulatory strategies and support successful implementation across markets
• Act as a trusted regulatory partner by coaching, sparring with, and guiding regulatory professionals, sharing knowledge and contributing to capability development within the organization
• Participating in departmental initiatives and continuous improvement projects that strengthen regulatory excellence and operational effectiveness

Qualifications

We are looking for a person who is comfortable speaking their mind, enjoys a challenging problem and has a strong personal drive with the ability to keep your spirit high under pressure. You have a professional and personal impact that is reflected in your desire to take initiative and finally, you must have a willingness to take responsibility for your own learning.

To Be a Competitive Candidate You Should Have

• Master’s degree or Ph.D. in science, pharmaceutical or health science
• Minimum 7-8 years of experience in Regulatory Affairs or other relevant area in drug development
• Practical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing
• Ability to communicate in fluent English (both written and spoken)
• Bring a can-do attitude and demonstrate a flexible, change-oriented approach
• Demonstrate proactivity and employ excellent project management skills
• Have a willingness to experiment and a tendency to view challenging situations as opportunities rather than limitations
• Are a skilled communicator who can cooperate at any organizational level
• Bring a positive attitude and are self-motivated

Department

You will join the Regulatory Affairs Obesity and Chronic Health (RA OCH) area, a team responsible for defining and driving regulatory strategies across Novo Nordisk's obesity and diabetes portfolio. As an integrated partner within global research and development projects, the department plays a critical role in shaping development plans, regulatory submissions, health authority interactions, and labelling strategies.

The team works closely with global stakeholders and affiliates around the world, creating a collaborative and international environment where diverse perspectives are valued. You will become part of a department committed to scientific excellence, continuous learning, and delivering meaningful outcomes for patients.

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 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.

Deadline

3rd October 26

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.