Regulatory Affairs Senior Manager
2 weeks ago
Job Title: Senior Manager of Regulatory Affairs
Company: Curium Live Forward
The Senior Manager of Regulatory Affairs is responsible for overseeing the regulatory activities associated with Nuclear Medicine in the United States. This position entails the formulation of compliant content for regulatory submissions, the management of tracking systems, and the preparation of electronic submissions. The ideal candidate will possess a comprehensive understanding of the regulatory environment concerning Chemistry, Manufacturing, and Controls (CMC), with a focus on new submissions for New Chemical Entities (NCE) and established products.
Key Responsibilities:
- Oversee submissions and projects delegated by Regulatory leadership
- Act as a representative for regulatory matters on cross-functional teams
- Provide regulatory and technical guidance
- Lead the preparation and submission of CMC sections within regulatory documents
- Develop and execute regulatory strategies for pharmaceutical development
- Contribute to the establishment of Target Product Profiles and compliant drug submissions
- Maintain a comprehensive database for tracking project milestones
- Align objectives with stakeholder expectations
- Communicate updates on policy changes and compliance strategies
- Mentor junior regulatory staff
- Ensure adherence to regulatory agency requirements
Qualifications:
- Bachelor's degree in Chemistry, Pharmacy, Biology, or a related life science field
- Minimum of 12 years of experience in Regulatory Affairs
- At least 2 years of experience in a supervisory role
- Extensive knowledge of global CMC regulatory standards
- Proven experience in leading new project submissions and drafting regulatory documents
- Familiarity with Health Authority meetings
Work Environment:
- Standard office setting
- Collaborative team environment
- May involve prolonged periods of sitting or standing
- Attention to detail is crucial
- Willingness to work flexible hours, including weekends and holidays
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