Regulatory Professional

Novo Nordisk A/S; Søborg; On-site; DKK 570,000 - 838,000; Full time

Job summary

Novo Nordisk A/S in Søborg, Denmark is seeking a Regulatory Professional in Affiliate Coordination & Optimization to plan, coordinate and execute national registration file documentation for global regulatory submissions. You will serve as the central contact for affiliates and HQ stakeholders, managing multiple submissions across overlapping timelines.

The role requires a Master’s degree in life sciences, strong English communication, and proven coordination skills.

Qualifications

• Master's degree in a relevant field such as life science, health science, pharmacy or similar
• Preferably experience from the pharmaceutical industry, regulatory affairs or a related business/process-oriented function, including coordination across functions and documentation handling
• Excellent communication skills in English, both written and verbal, with strong cultural awareness and the ability to influence and align diverse stakeholders in a global environment
• A well-organised and flexible approach, with the ability to prioritise and manage multiple assignments under tight deadlines without losing oversight
• A decisive and positive mindset, comfortable taking charge of deliveries, navigating change and driving progress in complex situations

Responsibilities

• Planning, coordinating and executing national registration file documentation for global regulatory submissions across the Novo Nordisk product portfolio
• Clarifying country-specific documentation needs with affiliates and assessing requirements against local regulations and submission timelines
• Preparing and coordinating additional regulatory documents such as pharmaceutical certificates and statements
• Driving progress with internal and external stakeholders, ensuring alignment and timely delivery across several simultaneous submissions at different stages
• Escalating risks or challenges in due time and proposing solutions based on regulatory requirements
• Contributing to continuous improvement of ACO processes to support fast submissions, approvals and regulatory compliance
• Sharing regulatory and process insights with colleagues and identifying opportunities to simplify and improve ways of working

Skills

Coordination

English proficiency

Organized & flexible

Stakeholder management

Problem solving

Education

Master's degree in life sciences

Job description

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Category: Reg Affairs & Safety Pharmacovigilance

Location: Søborg, Capital Region of Denmark, DK

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Are you energised by coordinating regulatory submissions across a global product portfolio, ensuring that the right documentation reaches health authorities worldwide, on time and in full compliance? Do you thrive when navigating complex timelines, diverse stakeholders and ever-changing regulations? If so, this is your opportunity to play a central role in bringing innovative treatments to patients around the world.

Your new role

As a Regulatory Professional in Affiliate Coordination & Optimization (ACO), you will be at the heart of planning, coordinating and executing national registration file documentation, including pharmaceutical certificates and statements, for submissions to health authorities worldwide. You will act as the central point of contact for affiliates and headquarters stakeholders, keeping multiple submissions on track across overlapping and often challenging timelines.

• Planning, coordinating and executing national registration file documentation for global regulatory submissions across the Novo Nordisk product portfolio
• Clarifying country-specific documentation needs with affiliates and assessing requirements against local regulations and submission timelines
• Preparing and coordinating additional regulatory documents such as pharmaceutical certificates and statements
• Driving progress with internal and external stakeholders, ensuring alignment and timely delivery across several simultaneous submissions at different stages
• Escalating risks or challenges in due time and proposing solutions based on regulatory requirements
• Contributing to continuous improvement of ACO processes to support fast submissions, approvals and regulatory compliance
• Sharing regulatory and process insights with colleagues and identifying opportunities to simplify and improve ways of working

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.

Affiliate Coordination & Optimization (ACO) sits within Regulatory, Quality & Clinical Operations. We are responsible for obtaining national documentation in compliance with health authority regulations for worldwide submissions, and we have the privilege of working across the entire Novo Nordisk product portfolio. We are a close-knit team of five dedicated and highly engaged colleagues with diverse backgrounds and experience. We collaborate broadly with stakeholders across the organisation, both at headquarters and in affiliates, and we continuously seek to improve our processes to keep pace with a constantly evolving global regulatory landscape. The atmosphere is informal, and a good sense of humour is always welcome.

Your skills & qualifications

To succeed in this role, we are looking for someone who combines strong coordination skills with a proactive, solution-oriented mindset and the ability to navigate complexity with clarity and confidence.

• A Master's degree in a relevant field such as life science, health science, pharmacy or similar
• Preferably experience from the pharmaceutical industry, regulatory affairs or a related business/process-oriented function, including coordination across functions and documentation handling
• Excellent communication skills in English, both written and verbal, with strong cultural awareness and the ability to influence and align diverse stakeholders in a global environment
• A well‑organised and flexible approach, with the ability to prioritise and manage multiple assignments under tight deadlines without losing oversight
• A decisive and positive mindset, comfortable taking charge of deliveries, navigating change and driving progress in complex situations

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'lljoin 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 from570,200to 838,100 DKKcorresponding 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

13 September 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.