Global Regulatory Affairs Lead - Submissions & Lifecycle

Novo Nordisk A/S; Søborg; Remote; DKK 651,000 - 957,000; Full time

Job summary

Novo Nordisk A/S in Søborg, Denmark, seeks a Senior Regulatory Affairs Professional to guide global regulatory submissions and interactions with Health Authorities across the product lifecycle.

You will translate complex regulatory requirements into clear direction, collaborate across research, development, safety, and commercial teams, and deliver outcomes with global impact, while managing multiple deliverables independently.

Qualifications

• Master’s degree in life sciences or PhD with relevant experience.
• Experience with regulatory submissions and Health Authority interactions.
• Strong written and spoken English.
• Ability to interpret complex scientific and regulatory information and communicate clearly.

Responsibilities

• Plan and coordinate global regulatory submissions including MAAs, CTAs, and lifecycle submissions.
• Develop submission strategies using regulatory intelligence.
• Prepare regulatory files, coordinate document creation, review and submission.
• Manage responses and follow-up with Health Authorities.
• Provide regulatory guidance to stakeholders and mentor colleagues.

Job description

Novo Nordisk A/S in Søborg, Denmark, seeks a Senior Regulatory Affairs Professional to guide global regulatory submissions and interactions with Health Authorities across the product lifecycle.

You will translate complex regulatory requirements into clear direction, collaborate across research, development, safety, and commercial teams, and deliver outcomes with global impact, while managing multiple deliverables independently.