Director, Regulatory Affairs CMC, Combination Products and Device

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 DescriptionThe Director, CMC Regulatory Affairs – Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex, high-impact device and combination product portfolios, programs, or regulatory domains. This role serves as a strategic thought partner in strategy and execution, to shape development and lifecycle strategy, anticipate regulatory risk, and enable successful global registration and lifecycle management. The Director operates at a strategic level across PDM, Global Regulatory Affairs, Quality, and other cross-functional functions, guiding decisions where regulatory pathways may be complex, evolving, or without clear precedent, while ensuring alignment with business priorities and long-term capability building.KEY RESPONSIBILITIESSet and lead global CMC regulatory strategy for complex device and combination product portfolios, programs, or critical regulatory workstreamsShape global regulatory approaches that support product development, registration, lifecycle management, patient supply continuity, and long-term business objectivesServe as a strategic partner with cross-functional team by influencing key development, manufacturing, control strategy, and lifecycle decisions with a clear understanding of regulatory risk and opportunityLead resolution of complex regulatory issues for combination product and device programs, including areas where regulations are evolving or where explicit precedent may be limitedGuide development of regulatory risk mitigation and contingency strategies across major programs and submissionsOversee regulatory strategy and execution for major global submissions, significant post-approval changes, and other critical regulatory milestones (IND/CTA, NDA/BLA/MAA, Notified Body Opinion)Represent CMC Regulatory Affairs during health authority interactions on CMC topics relevant to combination products and deviceDrive consistent interpretation and implementation of global regulations, standards, and policy trends relevant to devices and combination products, and influence internal approaches accordinglyAct as a bridge across global, regional, and functional stakeholders to ensure alignment, transparency, and execution against regulatory prioritiesContribute to the strategic direction of combination product and device regulatory capability, including process improvements, knowledge sharing, talent development, and future-facing regulatory practicesParticipate in external industry forums, conferences, or policy-shaping discussions, as appropriate, to strengthen external insight and help inform Gilead’s regulatory positionQUALIFICATIONSA scientific degree with extensive directly relevant experience in CMC, device or combination product development, and global regulatory affairs12+ years with BA/ BS10+ years with MA/ MS/ MBA8+ years with PharmD/ PhDSignificant experience defining and leading regulatory strategies for complex products, technologies, submissions, or regulatory domainsDeep knowledge of global regulatory requirements, standards, and evolving expectations relevant to devices and combination productsDemonstrated success influencing strategy and decision-making across senior cross-functional stakeholders in complex, matrixed environmentsStrong experience engaging with health authorities and shaping regulatory approaches for significant business and development milestonesDemonstrated strategic acumen, sound judgment, and ability to lead through ambiguity and changeAdvanced communication, presentation, and leadership skillsABOUT GILEADGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. GILEAD CORE VALUES · Integrity (Doing What’s Right) · Inclusion (Encouraging Diversity) · Teamwork (Working Together) · Excellence (Being Your Best) · Accountability (Taking Personal Responsibility) The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.For jobs in the United States: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. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact View email address on click.appcast.io for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTGilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.SummaryLocation: United States - California - Foster CityType: Full time