Global Regulatory Strategist, Drug Development

Novo Nordisk

Gladsaxe Kommune

On-site

DKK 743,000 - 1,092,000

Full time

19 hours ago
Be an early applicant
Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Novo Nordisk in Denmark is seeking a Regulatory Affairs Specialist to develop regulatory strategies and drive their execution across the GLP-1 portfolio, cooperating with the Global Regulatory Lead and cross‑functional teams. You will lead regulatory submissions, liaise with Health Authorities and affiliates, coach colleagues, and contribute to continuous regulatory excellence, with a focus on timely, high‑quality deliverables in a global environment.

The role requires a Master’s or Ph.D.

Qualifications

  • Master’s degree or Ph.D. in science, pharmaceutical or health science
  • 7–8 years of experience in Regulatory Affairs or related area in drug development
  • Knowledge of global regulatory strategies and regulatory documentation requirements
  • Fluent English (written and spoken)
  • Proactive, with project management skills and flexibility
  • Strong communication across organizational levels and self-motivation

Responsibilities

  • Contribute regulatory expertise to global development strategies and provide strategic recommendations
  • Lead regulatory submission activities including briefing packages and global submissions
  • Coordinate with affiliates and international stakeholders to align local and global regulatory strategies
  • Coach and guide regulatory professionals and contribute to capability development
  • Participate in department initiatives to strengthen regulatory excellence and operational effectiveness

Skills

Regulatory strategy
Project management
Global submissions
Stakeholder collaboration
English fluency

Education

Master’s degree or Ph.D. in science/health science

Job description

Novo Nordisk in Denmark is seeking a Regulatory Affairs Specialist to develop regulatory strategies and drive their execution across the GLP-1 portfolio, cooperating with the Global Regulatory Lead and cross‑functional teams. You will lead regulatory submissions, liaise with Health Authorities and affiliates, coach colleagues, and contribute to continuous regulatory excellence, with a focus on timely, high‑quality deliverables in a global environment.

The role requires a Master’s or Ph.D.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Global Regulatory Strategy Lead for GLP-1 Portfolio
Global Regulatory Strategy Lead for GLP-1 Portfolio

Novo Nordisk A/S • Søborg

On-site
DKK 743,000 - 1,092,000
Global Regulatory CMC Lead, Early Development
Global Regulatory CMC Lead, Early Development

Novo Nordisk A/S • Denmark

Remote
DKK 847,000 - 1,245,000
Principal Regulatory Strategy Lead, CMC & Global Submissions
Principal Regulatory Strategy Lead, CMC & Global Submissions

Novo Nordisk • Gladsaxe Kommune

On-site
DKK 847,000 - 1,245,000
Senior Clinical Pharmacology Lead — Global Development
Senior Clinical Pharmacology Lead — Global Development

Novo Nordisk A/S • Søborg

On-site
DKK 743,000 - 1,092,000
Regulatory Affairs Specialist
Regulatory Affairs Specialist

Novo Nordisk A/S • Søborg

On-site
DKK 743,000 - 1,092,000
Senior Clinical Pharmacology Scientist - Global Development
Senior Clinical Pharmacology Scientist - Global Development

Novo Nordisk A/S • Denmark

Remote
DKK 743,000 - 1,092,000
Regulatory Affairs Specialist
Regulatory Affairs Specialist

Novo Nordisk • Gladsaxe Kommune

On-site
DKK 743,000 - 1,092,000
Global Regulatory CMC Lead for Early Development
Global Regulatory CMC Lead for Early Development

Novo Nordisk A/S • Søborg

On-site
DKK 847,000 - 1,245,000
Senior Global Nonclinical Regulatory Submissions Specialist
Senior Global Nonclinical Regulatory Submissions Specialist

Novo Nordisk A/S • Denmark

Remote
DKK 651,000 - 957,000
Regulatory Submissions Lead — Nonclinical & Global
Regulatory Submissions Lead — Nonclinical & Global

Novo Nordisk A/S • Måløv

On-site
DKK 651,000 - 957,000