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Senior Director - Analytical Regulatory Science
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$307,560
Full-time
- By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibility the incumbent will support “right first time” global approvals for CMC control strategies and maintain “right to operate” throughout the product lifecycle.
- In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
- The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead.
- Evaluates and communicates risks for CMC control strategies and quality compliance to CMC RA and PDM leadership.
- Develops meaningful and collaborative relationships with cross-functional teams and leaders across CMC RA and PDM. Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks.
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