Role Description

• Strategic Leadership & Vision:
• Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and regulatory expectations.
• Champion regulatory innovation and novel approaches to accelerate development and approval timelines.
• Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices.
• Global Regulatory Excellence:
• Lead the development of global CMC regulatory initiatives focused on combination products and devices.
• Ensure regulatory conformance and consistency across markets, maintaining compliance with evolving health authority requirements and internal governance.
• Enterprise Collaboration & Influence:
• Cultivate strong, collaborative relationships across Gilead’s global functions, including Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain.
• Influence cross-functional decision-making and regulatory planning without direct authority, operating effectively in a matrixed environment.
• Remain apprised of the current best practices across the industry, as well as serve as a liaison across other regulatory functions.
• Program Oversight & Governance:
• Provide strategic direction and oversight for late-stage development programs.
• Guide combination and packaging development teams, ensuring integrated execution across all development functions.
• Lead major regulatory applications and lifecycle management strategies.
• Include early and late-stage programs in scope, as teams are working earlier on TPPs and product strategies.
• Regulatory Operations & Submissions:
• Oversee the drafting, review, and approval of CMC sections for regulatory filings.
• Provide leadership for agency interactions, inspections, and regulatory responses.
• Ensure readiness and compliance for global commercialization.
• Design Control & Technical Strategy:
• Provide strategic input to Design Control processes and documentation, ensuring alignment with FDA 21 CFR Part 4 and global technical standards.
• Contribute expertise to design history files, human factors studies, and process characterization.
• Leadership & Culture:
• Model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities.
• Foster a culture of integrity, excellence, and continuous improvement within the global CMC RA organization.

Qualifications

• A scientific degree with directly relevant professional experience in small molecule and biologics 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.
• Experience supporting multiple regulatory filings including IND/IDE and NDA/BLA and supporting product-related inspections for US and foreign regulatory agencies.
• In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics.
• Proven track record in the successful development and commercialization of device technologies, innovation, and championing business practice improvements.
• Experience leading major initiatives to improve organizational capabilities.
• Demonstrated strategic thinking and influencing skills internally and externally.
• Sound working knowledge of global regulatory requirements for Combination Products/ Devices.
• Excellent leadership, collaboration and communication skills, as well as the proven ability to drive innovation and influence organization change.
• Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation.

Requirements

• The salary range for this position is: $274,550.00 - $355,300.00.
• Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.

Benefits

• For additional benefits information, visit:

Gilead Benefits

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.