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Regulatory Affairs Director
2 months ago
Advanced Resource Managers is seeking an experienced Associate Director of Regulatory Affairs - CMC to lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.
Key Responsibilities:- Develop and execute CMC regulatory strategies for biological products in the EMEA region.
- Provide CMC regulatory guidance for the preparation of regulatory submissions to the EMA and regional agencies.
- Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products in regulatory filings such as MAA and variations.
- Perform change control impact assessments for CMC changes.
- Lead the CMC regulatory management and submission planning of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products.
- Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals.
This is a permanent full-time position offering a competitive salary and an extensive benefits package.
