Regulatory Affairs Director for CMC Operations
4 days ago
Key Responsibilities:
- Develop and lead regulatory CMC strategies for post-approval changes, ensuring compliance with global regulatory requirements.
- Represent Regulatory Affairs on cross-functional committees, project teams, and vendor/contractor meetings.
- Collaborate with Quality, External Operations, and Manufacturing teams to ensure regulatory compliance.
- Lead the preparation, review, and submission of regulatory CMC documentation and dossiers.
- Review and approve change controls, assessing regulatory impacts of product and process changes.
- Coordinate responses to CMC-related queries from Health Authorities.
- Offer regulatory and scientific expertise in writing and reviewing applications to ensure compliance and successful filings.
- Manage regulatory relationships with external CMOs and third-party packaging suppliers, assessing regulatory impact of proposed changes.
- Develop Health Authority meeting materials.
- Drive initiatives to enhance regulatory standards and practices within the organization.
- Monitor regulatory changes and communicate their impact to internal teams.
- Bachelor's degree in a scientific discipline required; post-graduate degree preferred.
- Relevant regulatory experience in post-approval CMC changes is required.
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