CMC Regulatory Expert
1 week ago
The successful candidate will be responsible for providing strategic, tactical, and operational regulatory input to projects in late development. This includes leading activities for synthetic small molecule projects, driving scientific and regulatory discussions, and working closely with stakeholders across multiple functions.
Key responsibilities include:
- Applying regulatory intelligence and establishing strategy for submission of clinical trial applications and marketing authorizations
- Submission of regulatory files and responding to questions from health authorities
- Ensuring preparation, review, and submission of pre-meeting packages for health authority meetings
- Addressing process challenges by performing analyses and proposing new ways to support projects
- Identifying phase-appropriate regulatory risks and developing mitigation strategies
Required Skills and Qualifications
A Master and/or Ph.D. degree in life sciences with regulatory CMC experience either from the pharmaceutical industry or from a health authority. Minimum 8+ years of experience with synthetic small molecules experience is preferred, as well as expertise in process design, analytical methodology, control strategy, process validation, and stability/shelf-life.
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