Exec Director, Regulatory Affairs-Combination Products & Devices

Gilead Sciences•Washington DC, DC

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job 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. In addition, 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.

Requirements

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.

Responsibilities

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. In addition, 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.

Benefits

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.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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