Regulatory Affairs Specialist in CVD/CKD Area

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Job Description:

We are seeking a highly skilled Regulatory Affairs Specialist 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.

Your key responsibilities will include driving regulatory strategies and clinical regulatory activities for assigned early to mid-stage development projects, leading health authority interactions, providing input to clinical and non-clinical development, and coordinating and planning all regulatory activities.

  • Lead Regulatory Activities: Oversee the RA Matrix team for assigned projects to ensure timely and high-quality regulatory deliverables to global project teams.
  • Collaborate with Colleagues: Work closely with colleagues, ensure knowledge sharing within and across projects, and provide sparring and mentoring to others.
  • Report to Head of RA CVD/CKD Team: Report to the Head of the RA CVD/CKD team and take an active part in department-related activities, including improvement projects across Global RA.
Qualifications:

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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