Sr Manager, 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 DescriptionJOB DESCRIPTIONThe Senior Manager, CMC Regulatory Affairs – Combination Products and Device is responsible for supporting CMC regulatory activities for development or lifecycle programs involving devices and combination products. This role supports the development and implementation of global regulatory strategy and is accountable for execution of high-quality regulatory submissions and lifecycle activities that support clinical development, product registration, and continued market supply. The Senior Manager partners closely with the Pharmaceutical Development & Manufacturing (PDM) team to ensure global regulatory requirements are incorporated into program planning and execution.KEY RESPONSIBILITIESContribute to the development and implementation of global CMC regulatory strategies for development, registration, and lifecycle management of combination productsServe as the CMC Regulatory Affairs Combination Product and Device Lead for assigned device and combination product programs or workstreamsInterpret and apply relevant global regulations, guidance, and evolving expectations relevant to devices and combination products to program work and strategyProvide regulatory input on device-related development activities, control strategy elements, design control documentation, and lifecycle changes needed to support regulatory submissionsSupport preparation and submission of high-quality CMC regulatory content for global submissions, including investigational, marketing applications, and post-approval submissions (IND/CTA, NDA/BLA/MAA, Notified Body Opinion)Partner with cross-functional stakeholders to support submission readiness, timeline execution, and resolution of CMC regulatory risks and issuesIdentify, communicate, and escalate regulatory risks or issues that may affect development, approval, or supply continuitySupport health authority interactions through preparation of background packages, responses to agency questions, and follow-up actionsConduct regulatory impact assessments driven by lifecycle management of marketed combination productsMaintain current knowledge of regulatory trends for devices and combination products and communicate relevant updates to project teamsSupport areas of priority to Gilead in policy/trade organization working groups for combination productsContribute to process improvement and operational excellence initiatives within CMC Regulatory AffairsDemonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities, as applicableQUALIFICATIONSUndergraduate or advanced degree in life sciences or related field with significant CMC, manufacturing, device, development, regulatory, or related experience in the biopharma or related industry8+ years with BA/ BS6+ years with MA/ MS/ MBA2+ years with PharmD/ PhDExperience supporting development and submissions management of regulatory filings, including experience leading routine to moderately complex CMC regulatory activitiesWorking knowledge of global CMC regulatory requirements relevant to devices and combination productsAbility to interpret technical information and translate it into clear regulatory actions and plansStrong collaboration, organizational, and project management skillsStrong verbal, written, and presentation skillsDemonstrated ability to work effectively across functions and influence without direct authorityABOUT 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: $157,590.00 - $203,940.00. 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