Sr Regulatory Affairs Professional (Denmark, Søborg)

Jobbeskrivelse

Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

Senior Regulatory Affairs Professional

Join us in three temporary roles where you'll shape the regulatory strategy for some of our most important pipeline products and help bring life-changing medicines to patients across the globe.

Your new role

We are looking for three (Senior) Regulatory Affairs CMC Professionals to join RA CMC & Device in temporary maternity cover roles across two different departments. Two roles are in the area handling life-cycle management and late-stage development for the semaglutide pipeline. One role is in a department within the RA CMC life-cycle management area, supporting drug product transfers to new manufacturing sites across the full portfolio. All roles offer the opportunity to become a subject matter expert in a leading international organisation and to take the lead in setting the strategic direction for products of great importance to Novo Nordisk's growth on a global level.

These temporary roles involve working with late-stage development and life-cycle management submissions worldwide, each anchored in a different department. You will be at the centre of project planning and execution, responsible for planning, coordinating, and reviewing regulatory documentation related to the drug product. This includes preparing applicable sections of submission packages, drafting responses to agency questions for global markets, and contributing to agency meeting packages.

You will be accountable for :

• Planning, executing and driving strategic regulatory CMC activities for late-stage development and life-cycle management submissions worldwide
• Applying CMC regulatory intelligence to develop robust regulatory strategies
• Identifying and improving regulatory CMC practices, processes, and approaches related to regulatory CMC documentation and strategies
• Preparing and coordinating submission packages and responses to health authority questions across global markets
• Collaborating across multidisciplinary project groups to ensure timely and high-quality regulatory deliverables

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.

Novo Nordisk Regulatory Affairs CMC & Device makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The three temporary roles are anchored in two different departments. Two roles are in the area handling life-cycle management and late-stage development for the semaglutide pipeline, an area consisting of approximately 40 employees in Denmark and India. One role is in a department within the RA CMC life-cycle management area, supporting drug product transfers to new manufacturing sites across the full portfolio. RA CMC LCM consists of approximately 50 employees in Denmark and India.

Your skills & qualifications:

• An academic degree in science, pharmacy, biology, or a similar field
• At least 1–2 years of relevant experience in the pharmaceutical industry, particularly within a CMC-related area, though we also welcome applicants with less experience if the match and mindset are right
• A strong scientific and technical mindset, along with a thorough understanding of related pharmaceutical operations such as manufacturing, process development, analytics, and quality assurance
• Excellent communication skills, both written and spoken, with fluency in English
• Strong collaboration skills, as all work takes place in multidisciplinary project groups

On a personal level, you are a curious, well-organised, and proactive problem solver who thrives in dynamic environments. With a can-do attitude and strong teamwork skills, you adapt to change effectively while bringing innovation and independence to overcoming challenges. In this role, your collaborative skills will be well-trained and further developed, allowing you to build an extensive internal network.

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 651,000 to 956,900 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
Please submit applications by 15 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.