Regulatory Affairs Director (Denmark, Søborg)

Jobbeskrivelse

Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

-

Are you passionate about shaping the future of regulatory science and enabling access to life-changing medicines?

As Regulatory Affairs Director, you will play a pivotal role in shaping global regulatory strategies for innovative medicines and helping bring new treatment options to patients around the world. We are looking for an experienced regulatory expert who brings broad expertise across multiple Regulatory Affairs disciplines, including experience from global, regional and affiliate organisations.

You are able to combine scientific insight, regulatory knowledge and business understanding to navigate complexity, influence key stakeholders and deliver impactful outcomes in a global environment.

Your new role
As Regulatory Affairs Director, you will be a key strategic partner across the value chain, shaping global regulatory strategies for some of Novo Nordisk’s most important lifecycle management projects. You will operate in a highly complex global environment, influencing critical business decisions and engaging directly with major health authorities to enable fast and sustainable patient access to innovative treatments.

In this role, you will serve as a recognised regulatory expert and strategic thought partner. You will be accountable for defining and executing global regulatory strategies across highly complex portfolios and projects, ensuring alignment between scientific innovation, business priorities and regulatory requirements.

• Act as Global Regulatory Project or Portfolio Lead for highly complex projects with significant strategic and business impact.
• Own and drive global regulatory strategies that support ambitious business objectives and successful product development.
• Lead regulatory activities for submissions and approvals, including CTAs, NDAs, BLAs, MAAs and indication expansions.
• Represent Novo Nordisk in interactions and negotiations with global regulatory authorities, including FDA, EMA, PMDA and other key agencies.
• Provide regulatory recommendations and strategic guidance to governance bodies, project teams and senior management.

Your new department
You will join a highly engaged and internationally diverse Regulatory Affairs organisation with a strong ambition to shape the future of regulatory science. We partner across Research & Development, Medical, Commercial, Legal and affiliate functions to bring innovative medicines to patients around the world.

Our culture is built on collaboration, trust, continuous learning and a shared commitment to improving the lives of people living with serious chronic diseases. The department is responsible for a portfolio of some of Novo Nordisk’s most important lifecycle management projects.

Your skills and qualifications
To succeed in this role, we imagine that you have:

• Significant Regulatory Affairs experience gained across multiple regulatory disciplines and functions, including global, regional and affiliate regulatory roles.
• A strong track record of developing and executing bold regulatory strategies across the product lifecycle and successfully navigating complex global regulatory environments.
• Extensive experience interacting and negotiating with major health authorities such as FDA, EMA, PMDA, NMPA and other key regulatory agencies.
• Proven ability to lead highly complex projects and influence cross-functional teams in a global matrix organization, demonstrating informal leadership.
• Excellent stakeholder management, communication and negotiation skills, with the ability to engage and influence senior leaders across functions, regions and cultures. An advanced scientific degree complemented by substantial experience within the pharmaceutical industry.

Working at Novo Nordisk
We're not chasing quick fixes – we're creating lasting change for long-term health. 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 940,800 to 1,448,700 DKK (DK), 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
23th August 2026. Applications will be reviewed on an ongoing basis.

-