Regulatory Affairs Professional
13 hours ago
We are seeking a highly skilled Regulatory Affairs Chemistry, Manufacturing and Control (RA CMC) Specialist to join our team at Novo Nordisk A/S.
In this role, you will be responsible for providing strategic regulatory input to projects, including developing regulatory strategies for submission of clinical trial applications (CTAs) and marketing authorizations (MAAs).
Responsibilities:- Preparation and submission of regulatory files, response to health authority questions, and participation in meetings
- Analysis of data to address process challenges and propose new ways to support projects
- Identification of phase-appropriate regulatory risks and development of mitigation strategies
- Regulatory assessment of planned or implemented CMC changes based on global regulatory guidelines
A Master's and/or Ph.D. degree in life sciences with regulatory CMC experience is essential. We prefer candidates with synthetic small molecules experience, specifically in process design, analytical methodology, control strategy, process validation, and stability/shelf-life.
Candidates should have in-depth knowledge of regulatory CMC requirements for clinical trial/investigational new drug applications and marketing authorizations in major countries.
We offer relocation assistance for selected candidates who require it.
Our commitment to innovation also applies to the way we work: we embrace the hybrid workplace where you can balance working from home and the office.
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