Global Regulatory Affairs Lead — Submissions & Strategy

Novo Nordisk; Gladsaxe Kommune; On-site; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk is seeking a Senior Regulatory Affairs Professional to guide global regulatory submissions and Health Authority interactions across the product lifecycle. You will work with colleagues from research, development, safety, clinical operations and commercial functions to translate complex requirements into regulatory direction.

The role requires a strong scientific background with relevant regulatory experience, excellent English, and the ability to manage multiple deliverables

Qualifications

• Master’s degree in life sciences with ~5–7 years relevant experience or PhD with ~3–4 years experience.
• Bachelor’s degree in life sciences with ~8–11 years experience or equivalent practical experience
• Experience with regulatory submissions in major markets (EU/US/China/Japan)

Responsibilities

• Plan and coordinate global regulatory submissions (marketing authorisation, trial applications, lifecycle submissions).
• Apply regulatory intelligence to develop submission strategies, plans, and timelines.
• Prepare regulatory files and coordinate document creation, review, and submission.
• Manage responses and follow-up with Health Authorities.
• Plan and support interactions with Health Authorities, including meetings and briefings.
• Develop and maintain core labelling, including ECDS and European labelling.
• Provide regulatory guidance to stakeholders and mentor less-experienced colleagues.

Skills

Regulatory submissions

Regulatory intelligence

Cross-functional collaboration

English proficiency

Independent work

Education

Master’s degree in life sciences

PhD in life sciences

Bachelor’s degree in life sciences

Job description

Novo Nordisk is seeking a Senior Regulatory Affairs Professional to guide global regulatory submissions and Health Authority interactions across the product lifecycle. You will work with colleagues from research, development, safety, clinical operations and commercial functions to translate complex requirements into regulatory direction.

The role requires a strong scientific background with relevant regulatory experience, excellent English, and the ability to manage multiple deliverables