Chemistry, Manufacturing & Control (CMC) Regulatory Expert
In this pivotal role as Associate Director, you will lead the development and execution of cutting-edge CMC strategies to drive regulatory excellence across our diverse portfolio.
Key Responsibilities:
1. Lead global CMC regulatory strategy and execution for innovation projects, post-approval changes, lifecycle management, and compliance.
2. Oversee the preparation, review, and submission of high-quality CMC documentation for global health authority submissions.
3. Develop response strategies for regulatory queries and deficiency letters related to CMC matters.
4. Collaborate with cross-functional teams to ensure regulatory alignment with commercial strategy.
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