Head of CMC Regulatory Affairs – Small Molecules

Gilead Sciences•Foster City, CA

19h

About The Position

At Gilead, we are dedicated to creating a healthier world by tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer through relentless development of therapies and ensuring global access. The company values collaboration, determination, and a drive to make a difference, with every employee playing a critical role. This position, Head of CMC Regulatory Affairs – Small Molecules, is a leadership role responsible for guiding CMC teams and groups to achieve product and portfolio regulatory affairs goals. The role involves developing and executing global CMC regulatory strategies, including risk mitigation, to ensure successful and timely approvals of product submissions and to maintain global licensure for Gilead's operations. The Head will also lead the integration of CMC Team Leaders and Regulatory Scientists, develop solutions for complex CMC challenges from clinical development through commercial registration, and ensure regulatory conformance globally. This role requires partnering across various functional groups within Gilead to foster innovation and build strong internal and external relationships. The successful candidate will also be responsible for demonstrating Gilead's core values and leadership commitments, influencing within a matrixed organization, and driving continuous improvement and talent development within the Small Molecules organization.

Requirements

A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD.
Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.).
Experience with leading NDA/BLA submission and approvals including global Health Authority Interactions.
Application of sound and accurate judgment to make timely decisions.
Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
Demonstrated organizational leadership skills at both functional and enterprise levels.
Excellent strategic acumen, collaboration, and communication skills are required.

Responsibilities

Lead CMC teams/ groups to support the CMC product and portfolio regulatory affairs goals and contribute to the development of global regulatory initiatives.
Lead global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions.
Develop 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.
Lead the integration and implementation of CMC Team Leaders and CMC Strategies (Regulatory Scientists).
Lead 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 for support with opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
Develop meaningful and collaborative relationships with local & global internal/ external partners.
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.
Drive the continuous improvement and cultural evolution of the Small Molecules organization while promoting development of talent at all levels.