Global Publishing & Archive Lead

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

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.