Assoc Director, Regulatory Affairs CMC

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 DescriptionJOB DESCRIPTIONThe Associate Director, CMC Regulatory Affairs – Combination Products and Device is responsible for defining and advancing global CMC regulatory strategy for products, platforms, or major workstreams involving devices and combination products. This role ensures that regulatory strategy is integrated into development and lifecycle planning and that submissions are executed in a manner that supports approvability, business objectives, and continuity of supply. The Associate Director acts as a strategic partner across Pharmaceutical Development & Manufacturing (PDM) and cross-functional teams by translating complex technical, development, and regulatory considerations into clear regulatory pathways, risk-based recommendations, and executable plans.KEY RESPONSIBILITIESDefine and lead global CMC regulatory strategy for device and combination product programs across development, registration, and lifecycle managementEnsure regulatory strategy is integrated into cross-functional program plans and aligned with business objectives, development milestones, and supply considerationsLead global regulatory planning and oversight for complex global submissions and post-approval changes involving device and combination product content (IND/CTA, NDA/BLA/MAA, Notified Body Opinion)Provide strategic regulatory advice to PDM cross-functional stakeholders on development pathways, design control considerations, human factors, and lifecycle approaches relevant to regulatory submissionsInterpret and apply global regulations, guidance, and policy trends to shape regulatory strategies and support successful submissions and approvalsLead cross-functional evaluation of regulatory risks, tradeoffs, and mitigation plans, and drive alignment on recommended paths forwardPartner with global and regional regulatory colleagues to ensure coordinated strategy, strong communication, and market-specific readinessPlay a lead role in preparation for health authority interactions, including briefing materials, strategic positioning, and responses to agency questions relevant to combination products and devicesInfluence cross-functional stakeholders to anticipate regulatory implications early and incorporate them into development and lifecycle decisionsLead or contribute to initiatives that improve regulatory processes, tools, ways of working, and knowledge management across the functionSupport building organizational awareness and knowledge build of combination products and devices, and associated global regulatory landscapeQUALIFICATIONSA scientific degree with directly relevant professional experience in CMC, device or combination product development, and global regulatory affairs10+ years with BA/ BS8+ years with MA/ MS/ MBA5+ years with PharmD/ PhDSignificant experience leading development and submission management of regulatory filings ranging from routine to highly complexStrong knowledge of the global CMC regulatory landscape for devices and combination products, including key market expectations and evolving regulatory trendsDemonstrated ability to interpret technical CMC and device information and translate it into effective regulatory strategyProven ability to influence cross-functional decision-making and operate as a strategic partner within complex development environmentsStrong communication, presentation, and stakeholder management skillsDemonstrated ability to lead through ambiguity, manage competing priorities, and guide teams through complex regulatory challengesABOUT 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: $182,070.00 - $235,620.00. 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