Associate Director Global Regulatory CMC
Our Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients.
Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines.
Position Summary :
The Regulatory CMC Development Associate Director will play a pivotal role in the Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for our product development programs.
This individual will be responsible for leading CMC regulatory submissions and ensuring compliance with global regulatory requirements.
The ideal candidate will possess a strong background in pharmaceutical manufacturing, regulatory affairs, and CMC documentation.
Key Responsibilities :
Regulatory Strategy Development :
- Develop and implement CMC regulatory strategies for drug development programs.
- Provide regulatory guidance and expertise to cross-functional teams throughout the product lifecycle.
CMC Documentation and Submissions :
- Lead the preparation, review, and submission of high-quality CMC sections of regulatory documents (e.g., INDs, NDAs, BLAs, MAAs).
- Ensure that CMC documentation meets global regulatory requirements and guidelines.
Regulatory Compliance and Communication :
- Monitor and interpret global CMC regulatory requirements and ensure company compliance.
- Liaise with regulatory agencies to facilitate CMC submissions and address regulatory inquiries.
Cross-Functional Collaboration :
- Work closely with R&D, Quality, Manufacturing, and other departments to gather necessary data and documentation.
- Support the development and implementation of CMC regulatory strategies for new products and lifecycle management of existing products.
Team Leadership and Development :
- Mentor and train junior regulatory staff on CMC regulatory processes and requirements.
- Foster a collaborative and innovative regulatory environment within the team.
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