Regulatory Affairs Specialist
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Søborg • Denmark
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About the role
- Developing regulatory strategies and lead their execution via interaction with cross-functional teams
- Leading major submission tracks such as briefing packages for meetings with Health Authorities, clinical trial applications, and global submission strategies
- Working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation
- Reporting to the head of the department and taking active part in department related activities, including improvement projects across RA.
Requirements
- A Master’s degree or Ph.D. in science, pharmaceutical or health science
- Minimum 7-8 years of experience in Regulatory Affairs or other relevant area in drug development
- Practical knowledge in defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing
- Excellent project management skills and ability to cooperate at any organizational level
- Change-oriented approach and a willingness to experiment
- Strong communication skills in verbal and written English.
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory documentationdrug developmentclinical trial applicationsglobal submission strategiesproject management
Soft Skills
communication skillscooperationchange-oriented approachwillingness to experiment
Certifications
Master’s degreePh.D.