Vice President, Global Head of Regulatory Affairs, CMC & Device
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Søborg • Denmark
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Job Level
About the role
- Provide leadership for the GRA CMC and Device function
- Overseeing regulatory submissions and ensuring regulatory maintenance of registered products in accordance with regulatory standards
- Being accountable for the oversight, planning and execution of all product supply activities requiring regulatory submission
- Leading, coaching and developing your direct reports and the whole team
- Fostering a culture of innovation, collaboration, and professional growth that is aligned with the Novo Nordisk Way
- Identifying and developing talents, ensuring succession planning, and participating in cross-organizational development activities
- Managing organizational design and building organizational capabilities to drive excellence in execution
- Fostering strong partnerships with Product Supply, Manufacturing, and Device and Pharma Development areas of the business
- Facilitating scientific exchange within regulatory CMC and medical devices across therapeutic areas, development projects, and existing products
Requirements
- Master’s or PhD in Pharmacy or other relevant disciplines
- 15+ years of experience in pharma regulatory affairs coupled with CMC regulatory affairs experience
- Significant track record in strategic leadership roles in regulatory affairs with a large pharma organization
- Line management experience from other parts of R&D would be an advantage
- Strong leadership capabilities
- Proven track record of creating business results with impact at executive level
- Extensive experience of successfully managing external collaborations with Health Authorities, Governments, Ministries of Health Industry Associations etc.
- Experience navigating international multi-disciplinary teams in complex matrix settings and ability to collaborate and build partnerships
- Proven track record of line management and matrix leadership
- Experience developing and coaching high performing teams and fostering an open culture of innovation and collaboration
- Superb communication and negotiation skills
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsregulatory maintenanceproduct supply activitiesCMC regulatory affairsstrategic leadershipline managementcollaborations with Health Authoritiesmatrix leadershipcoaching high performing teams
Soft skills
leadership capabilitiescommunication skillsnegotiation skillscollaborationinnovationorganizational designtalent developmentsuccession planningfostering partnerships
Certifications
Master’s in PharmacyPhD in Pharmacy