Gilead Sciences is looking for an Executive Director, Regulatory Affairs-Combination Products & Devices to define and drive global regulatory strategies, ensuring alignment with corporate goals. You will provide strategic direction for late-stage development programs and major regulatory applications in a complex, matrixed environment.
What You'll Do
- Define and drive global regulatory strategies for combination products and devices.
- Champion regulatory innovation and novel approaches to accelerate development and approval timelines.
- Provide guidance to Product Development and Device Teams to align development and regulatory paths.
- 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.
- Cultivate strong, collaborative relationships across global functions including Quality, Manufacturing, Technical Development, Clinical Development, and Supply Chain.
- Influence cross-functional decision-making and regulatory planning without direct authority.
- Remain apprised of current industry best practices and 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.
- 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.
What We're Looking For
- A scientific degree with 16+ years of directly relevant professional experience with a BA/BS, or 14+ years with an MA/MS, PhD, PharmD, or MD. Experience must be in small molecule and biologics development, global CMC regulatory affairs, and CMC technical areas.
- Demonstrated track record in leading CMC regulatory affairs initiatives and innovative CMC regulatory strategies.
- Leadership experience in international regulatory/industry forums (e.g., ICH, PhRMA, ISPE, IQ, Bios).
- Experience leading NDA/BLA submissions and approvals, including global Health Authority Interactions.
- Application of sound and accurate judgment to make timely decisions.
- Proven success in leading complex groups to support operational goals and contribute to global regulatory initiatives.
- Demonstrated organizational leadership skills at both functional and enterprise levels.
- Excellent strategic acumen, collaboration, and communication skills.
- 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, with proven ability to drive innovation and influence organizational change.
- Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation.
Team & Environment
This role operates in a matrixed environment, influencing cross-functional decision-making and regulatory planning without direct authority.
Benefits & Compensation
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
- Compensation range: Other US Locations: $274,550.00 - $355,300.00. Bay Area: $302,005.00 - $390,830.00.
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.
