Role highlights
Full Time
Permanent
Senior
On-site
The Senior Regulatory Professional role at Novo Nordisk requires a Master's degree in life sciences and 4-5 years of experience in regulatory affairs or drug development, preferably with additional background in Clinical Operations, Medical Writing, or Research. The candidate must possess strong expertise in global regulatory approval processes, particularly within rare bleeding disorders and phase 3 clinical trial environments. Key competencies include developing comprehensive regulatory documentation such as information packages for health authority meetings, response packages, and regulatory files for marketing authorization. The role demands proficiency in managing multiple regulatory tasks under challenging and overlapping timelines, contributing to global regulatory strategies, and collaborating effectively within cross-functional teams comprising project management, medical and non-clinical specialists, statisticians, and medical writers. Excellent communication skills and the ability to act as a strategic business partner at all organizational levels are essential. Fluency in written and spoken English is required. The ideal candidate thrives in fast-paced, dynamic, and unfamiliar settings, demonstrating flexibility, a proactive attitude, and a collaborative mindset. Experience working in a global regulatory matrix environment and engaging with diverse stakeholders is important. The role also involves active participation in department improvement projects and fostering knowledge sharing within a multicultural team. Overall, this position demands a senior-level regulatory affairs professional with a strategic outlook, robust regulatory knowledge, and strong interpersonal skills to drive successful regulatory submissions and approvals in a complex, global pharmaceutical setting.
About the role
Role Summary
- Join Global Regulatory Affairs (GRA) at Novo Nordisk, focusing on rare bleeding disorders
- Contribute to global drug development and regulatory approval processes
- Work in a dynamic, cross-functional environment with a focus on patient outcomes
Responsibilities
- Drive multiple regulatory tasks with challenging and overlapping timelines
- Serve as a member of cross-functional project and submission teams
- Interact with stakeholders from various departments
- Participate in clinical trial teams responsible for applications, amendments, and reports
- Develop regulatory documentation for health authority submissions, including:
- Information packages for authority meetings
- Response packages for health authorities
- Regulatory files for marketing authorisation
- Contribute to global regulatory strategies and tactics
- Engage in project team decisions and discussions
- Collaborate with project management, medical and non-clinical specialists, statisticians, and medical writers
- Participate in department activities and improvement projects across Regulatory Affairs
Department
- RA Rare Bleeding Disorders is part of Global Regulatory Affairs, based in Søborg, Denmark
- Team of 14 employees from 8 nationalities with diverse backgrounds
- Emphasises trust, openness, sparring, challenge, and knowledge sharing
- Responsible for regulatory strategies, product labelling, Health Authority interactions, and clinical trial applications
- Collaborates with affiliates and works in global regulatory matrix teams
Requirements
- Master’s degree in life science
- 4-5 years of regulatory or drug development experience
- Advantageous to have background in Clinical Operation, Medical Writing, or Research
- Skilled communicator and strategic business partner at any organisational level
- Fluent written and spoken English
Personal Qualities
- Thrive in fast-paced, unfamiliar environments
- Can-do spirit and healthy sense of humor
- Flexible, change-oriented, and experimental mindset
- Team player and active contributor to team success
Benefits
- Opportunity to work on a phase 3 rare disease project
- Experience with global regulatory approval processes
- Inclusive and innovative team culture
How to Apply
- For more information, contact Senior Director Jane Møll Pedersen at +45 30 75 37 59
- Application deadline: 1st of December 2025
- Applications reviewed on an ongoing basis; position may close before the deadline
- Job title may be subject to change during the recruitment process
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