Gilead Sciences · 1 day ago
Exec Director, Regulatory Affairs-Combination Products & Devices
San Francisco Bay Area
Full-time
Onsite
Director/Executive
$275K/yr - $391K/yr
14+ years expGilead Sciences is dedicated to creating a healthier world by tackling significant health challenges. The Exec Director of Regulatory Affairs will define and drive global regulatory strategies for combination products and devices, ensuring compliance and collaboration across various functions within the organization.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
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
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
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
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
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
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
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
Qualification
Required
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
Benefits
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-13
Company data provided by crunchbase