Senior Director, CMC Regulatory Affairs – Biologics Project Lead

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Job Description
 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

About the Role:

The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix team of professionals, who work with a specific product in Gilead’s global portfolio of biological products in CMC Regulatory Affairs. This position will provide leadership at a product level as a global lead that ensures “right first time” global approvals of CMC regulatory (Biologics) submissions, and “right to operate” by maintaining the global licensures. In addition, the Sr Director will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions.

The leader will also be responsible for
ensuring the projects they are responsible for have a cohesive regulatory

strategy that is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. The role will report directly to Head of CMC Regulatory Affairs – Biologics at Gilead.

Specific Responsibilities and Skills

• Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions.

• Implement global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead’s operations.

• Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.

• Guide the development of regulatory strategies and solutions for complex CMC challenges

• for Clinical through Growth (newly approved) products submission, commercial registration, including risk mitigation.

• Exercise expertise in the interpretation and implementation of ICH guidelines with a goal of an approved/ harmonized regulatory control strategy.

• Ensure regulatory conformance & consistency for assigned products globally in compliance with regulatory requirements and internal procedures.

• Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead.

• Promote th