Regulatory Affairs Director for Biologics and Rare Diseases
1 week ago
About the Position
The RA CMC organization is growing, and we are strengthening our leadership team with a new Director with strong experience and interest in Regulatory Life Cycle Management. As the Director for RA CMC Biologics & Rare Diseases, you will play a pivotal role in shaping the future of RA CMC.
Key Responsibilities
- Accountable for the overall development and execution of regulatory CMC strategies and global approvals for the Biologics & Rare Diseases product portfolio.
- Inspire, empower, and develop leaders and employees with a focus on optimising the way we work and stakeholder collaboration.
- Set strategic direction and drive performance leveraging your leadership expertise and business understanding.
- Build and maintain strong relationships with key stakeholders, influence across levels, and value diverse perspectives.
About You
We are looking for a dynamic and visionary leader to spearhead our team as the Director of a newly established area. This is your chance to significantly impact and develop an area responsible for regulatory CMC strategies, driving excellence in our pipeline, and delivering regulatory approvals in close collaboration with key stakeholders.
Your Background
To thrive and succeed in this role, we would expect you to have:
- A Master of Science degree in natural sciences such as engineering, pharmacy, chemistry or similar.
- 10+ years of experience as a leader and minimum 5 years as second line leadership is required.
- 10+ years of experience from the pharmaceutical industry within Regulatory Affairs.
- Experience from working in a global function with manufacturing or CMC, QA or a function collaborating closely with regulatory CMC is an advantage.
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Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeWe are seeking an experienced purpose-driven and business-minded second line leader with extensive expertise in drug regulatory affairs to join our team as the Director of Regulatory Affairs for Biologics and Rare Diseases.About the roleAs the Director for RA CMC Biologics & Rare Diseases, you will play a pivotal role in shaping the future of RA CMC. We are...
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