[Hiring] Executive Director, Regulatory Affairs-Combination Products & Devices @Gilead Sciences

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.