Regulatory Affairs Professional
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Søborg • Denmark
Visit company websiteExplore more
About the role
- Develop and manage regulatory submissions and documentation across US, EU, and RoW
- Plan and coordinate submission and roll-out of Sema NDAs and brand variations
- Create content plans for various submission types, including NDAs/MAAs, variations, and supplements
- Prepare country-specific Module 1 documents and regional submission components
- Ensure compliance with regulatory agency requirements and regional laws
Requirements
- Bachelor or Master of Science (life sciences) and/or relevant PhD
- 3-7 years of experience in regulatory affairs within pharmaceutical or biotechnology sectors
- Proven expertise in product registration and regulatory strategy
- Fluent in written and spoken English
Benefits
- Opportunities to learn and develop
- Health insurance
- Pension scheme
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsdocumentation managementproduct registrationregulatory strategycontent planningModule 1 documents preparation
Soft Skills
communicationcoordinationplanning
Certifications
Bachelor of ScienceMaster of SciencePhD