Vice President, Global Head of Regulatory Affairs, CMC & Device

Are you an experienced and forward-thinking Regulatory Affairs Leader?  Do you thrive in a complex multi-functional international environment? Would you like to join smart, passionate and mission-driven colleagues that serve hundreds of millions of patients living with serious chronic diseases. If it sounds like you, then read on and apply today!  

We are looking for a VP Regulatory Affairs for Chemistry, Manufacturing and Control (CMC) and Devices that will lead CMC and Device area within Global Regulatory Affairs (GRA). This is a rare opportunity to join an accomplished GRA team with a focus on driving a high degree of innovation that reflect the evolving market environment. Reporting to Senior Vice President, Global Regulatory, R&D Quality & Clinical Reporting (RQC) you will own the strategy and execution for the area and will lead a 200 people team of experienced and highly dedicated colleagues. You will be a member of the RQC leadership team and will play an important role in fostering cross-functional collaboration across the value chain, drive interactions with key external stakeholders and provide a valuable contribution to the decision making up to executive level. 

The position is based in Soborg, Greater Copenhagen, Denmark. We welcome applications from candidates based in Denmark and those that are willing to relocate.  

Key responsibilities 

• Provide leadership for the GRA CMC and Device function. This includes setting the strategic direction, developing short- and long-term priorities consistent with Novo Nordisk’s strategy and ensuring its successful execution.  

• 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. 

Qualifications 
We are looking for an experienced leader with the following qualifications: 

• 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. The successful candidate should demonstrate a 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  

Working at Novo Nordisk 

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results. 

Deadline 
We look forward to receiving your application latest by 25th of January.