Global Publishing & Regulatory Archive Lead

Cari; København; Hybrid; DKK 847,000 - 1,245,000; Full time

Job summary

Novo Nordisk in Søborg, Denmark, is seeking an Associate Director, Publishing & Archive to lead a global publishing and archiving team within Regulatory, Quality & Clinical Reporting Operations (RQ&C Ops).

You will drive eCTD publishing excellence, build strategic partnerships across R&D, QA, IT and senior leadership, and shape the future direction of regulatory submissions while ensuring compliant, high-quality deliverables.

Qualifications

• Master's degree in a relevant pharmaceutical discipline with leadership experience.
• Deep understanding of drug development processes, GxP requirements and global regulatory guidelines.
• Strong expertise in eCTD publishing and regulatory submission requirements (EMA, FDA, PMDA).
• Excellent stakeholder management and ability to influence cross-functional teams and senior leaders.
• Collaborative, resilient leadership focused on developing people and delivering results with integrity.

Responsibilities

• Lead and develop a high-performing team, setting clear direction and prioritising activities.
• Drive business performance through objectives, resources, and milestones in publishing.
• Maintain quality and environmental standards via the local Quality Management System.
• Build partnerships with Regulatory Affairs, Clinical Reporting, R&D, QA, and DDIT, plus external authorities.
• Contribute to strategic decisions and represent Novo Nordisk in external forums on regulatory operations.

Skills

Leadership

Regulatory ops

eCTD publishing

Stakeholder mgmt

Cross-functional

Education

Master's degree

Tools

Regulatory submissions systems

Job description

Novo Nordisk in Søborg, Denmark, is seeking an Associate Director, Publishing & Archive to lead a global publishing and archiving team within Regulatory, Quality & Clinical Reporting Operations (RQ&C Ops).

You will drive eCTD publishing excellence, build strategic partnerships across R&D, QA, IT and senior leadership, and shape the future direction of regulatory submissions while ensuring compliant, high-quality deliverables.