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CVD/CKD Regulatory Lead Position at Novo Nordisk
2 weeks ago
About the Role:
We are seeking a highly skilled Global Regulatory Lead to join our team in the Cardiovascular & Chronic Kidney Diseases (CVD/CKD) therapeutic area.
As a Global Regulatory Lead, you will be responsible for developing regulatory strategies and executing various regulatory tasks within cross-functional project teams.
You will lead the development of regulatory strategies and execute various regulatory tasks within cross-functional project teams, interacting with a diverse array of stakeholders throughout the process.
- Drive Regulatory Strategies: Develop and execute regulatory strategies for assigned early to mid-stage development projects.
- Collaborate with Project Teams: Be a member of cross-functional project teams, interacting with various stakeholders from different departments in Novo Nordisk.
- Lead Regulatory Activities: Oversee the RA Matrix team for assigned projects to ensure timely and high-quality regulatory deliverables to global project teams.
Your key responsibilities will include:
- Developing Regulatory Strategies: Drive regulatory strategies and clinical regulatory activities for assigned early to mid-stage development projects.
- Leading Health Authority Interactions: Lead health authority interactions and provide input to clinical and non-clinical development.
- Coordinating Regulatory Activities: Coordinate and plan all regulatory activities, including leading the RA Matrix team for assigned projects.
To succeed in this role, we expect you to have a master's degree within life sciences with 7+ years of relevant experience and/or a PhD with 5+ years of relevant working experience within a pharmaceutical/biotech company, including global experience working in a company headquarters setting.
You should also have solid regulatory experience including health authority interactions and a comprehensive understanding of regulatory requirements for drug development.
A drive for science and innovation, the ability to understand complex scientific issues, and to bring them into a regulatory context while displaying a strategic mindset is essential.
Additionally, you should possess strong organizational and project management skills with problem-solving capabilities and excellent communication skills and comfort using fluent written and spoken English daily.
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