Associate Director, Publishing & Archive

Novo Nordisk A/S; Søborg; On-site; DKK 847,000 - 1,245,000; Full time

Job summary

Novo Nordisk A/S in Søborg, Denmark seeks an Associate Director of Publishing & Archive to lead a specialised team handling global publishing and archiving for regulatory submissions. You will be the SME for eCTD publishing, shaping the function’s future through improvements and strategic collaboration.

The role combines people leadership with regulatory expertise, engaging with senior leadership and external authorities to drive high-quality submissions worldwide.

Qualifications

• Master's degree and significant regulatory operations experience, including leadership.
• Deep understanding of drug development processes, GxP, and global guidelines.
• Strong expertise in eCTD publishing and regulatory submissions (EMA, FDA, PMDA).
• Excellent stakeholder management and communication, with cross-functional influence.
• A collaborative, resilient leadership style focused on development and results.

Responsibilities

• Leading, coaching and developing a high-performing publishing & archive team.
• Drive performance with clear objectives and efficient resource use.
• Maintain quality, compliance and environmental management in QMS.
• Build partnerships across Regulatory Affairs, Clinical Reporting, R&D, QA, and DD/IT.
• Contribute to strategic decisions and represent Novo Nordisk externally.

Skills

People leadership

Regulatory operations

eCTD publishing

Stakeholder management

Strategic influence

Education

Master's degree

Pharmaceutical discipline knowledge

Job description

Associate Director, Publishing & Archive

Category: Reg Affairs & Safety Pharmacovigilance

Location: Søborg, Capital Region of Denmark, DK

Do you want to shape how life-changing medicines reach patients around the world? As Associate Director, Publishing & Archive, you will lead a highly specialised team responsible for ensuring global regulatory submissions are delivered with the highest levels of quality, compliance and operational excellence.

Position to be based in Søborg, Denmark.

This is a unique opportunity to combine people leadership, strategic influence and regulatory expertise in a role that directly supports Novo Nordisk's mission of defeating serious chronic diseases.

Your New Role

As Associate Director, Publishing & Archive, you will provide leadership for a team responsible for global publishing activities and archiving. You will act as a key subject matter expert for electronic Common Technical Document (eCTD) publishing, while helping to shape the future direction of the function through continuous improvement, operational excellence and strategic collaboration.

Your responsibilities will include:

• Leading, coaching and developing a high-performing team, creating clarity of direction, enabling growth and ensuring effective prioritisation of activities.
• Driving business performance through clear objectives, efficient resource utilisation and successful delivery of critical publishing milestones.
• Ensuring quality, compliance and environmental management standards are maintained through a robust local Quality Management System.
• Building strong partnerships across Regulatory Affairs, Clinical Reporting, R&D, Quality Assurance, DD&IT and senior leadership, while engaging with external authorities and industry stakeholders.
• Contributing to strategic decision-making and representing Novo Nordisk in external industry forums that help influence the future of regulatory operations and submission standards.

In this role, you will have a direct impact on the successful delivery of regulatory submissions worldwide, helping ensure that innovative medicines can reach the patients who need them.

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.

Within R&D, the Publishing & Archive department is part of Regulatory, Quality & Clinical Reporting Operations (RQ&C Ops). The team plays a critical role in ensuring that regulatory submissions are compliant, accurately structured and delivered across major global health authority regions, including Europe, the United States, Japan and China.

In addition, the department oversees the archiving of regulatory and Trial Master File documentation in accordance with international regulatory requirements. As Associate Director, you will lead a team whose work directly contributes to bringing new medicines to patients around the world.

Your Skills and Qualifications

We are looking for an experienced leader who combines strong regulatory knowledge with the ability to inspire and develop people. You thrive in a complex stakeholder environment and enjoy balancing strategic priorities with operational execution.

To succeed in this role, you will ideally have:

• A Master's degree and significant experience within regulatory operations, publishing, archiving or related pharmaceutical discipline, including leadership experience.
• Deep understanding of drug development processes, GxP requirements, and relevant global regulatory guidelines.
• Strong expertise in eCTD publishing and regulatory submission requirements across major health authorities such as EMA, FDA and PMDA.
• Excellent stakeholder management and communication skills, with the ability to influence cross-functional teams and senior leaders.
• A collaborative and resilient leadership style, with a passion for developing people, driving continuous improvement and delivering results with integrity.

Working at Novo Nordisk

Every day we seek 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

Salary: For this role, the Annual Base Salary ranges from 847,000 to 1,245,100 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 .

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.

Contact

For further information about the position, please contact Klaus Kjær Laigaard at [e-mail]

Deadline

11. October 2026. Applications are reviewed on an ongoing basis.

We commit to an inclusive recruitment process and equal opportunity for all our job applicants.

At Novo we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company in the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.