Head of CMC Regulatory Affairs – Small Molecules

Arbeitsbeschreibung

JOB DESCRIPTION

• 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.

QUALIFICATIONS

• 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.

Gilead Core Values

· Integrity (Doing What’s Right)

· Inclusion (Encouraging Diversity)

· Teamwork (Working Together)

· Excellence (Being Your Best)

· Accountability (Taking Personal Responsibility)