Senior Director, CMC Regulatory Affairs Biologics Project Lead

7 days ago

Foster City, California, United States BioSpace, Inc. Full time
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.

Key Responsibilities:
  • 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 the use of novel approaches within project teams to resolve issues and problems.
  • Develop meaningful and collaborative relationships with cross-functional teams and leaders.
  • Lead CMC strategies, assess risks, and develop contingency plans, including major, complex applications.
  • Demonstrate and model Gilead's Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity.
  • Demonstrate success in influencing without positional authority within a highly matrixed organization.
Requirements:
  • A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
  • Demonstrated track record in defining innovative CMC regulatory strategies, and implementing at a platform level.
  • Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
  • Application of sound and accurate judgment to make timely decisions.
  • Demonstrated organizational leadership skills at a functional level.
  • Excellent strategic acumen, collaboration, and communication skills are required.
  • Demonstrated commitment to inclusion, developing talent and empowering teams.

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