Sr Manager, Regulatory Affairs CMC, Combination Products and Device

About this role

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   JOB DESCRIPTION The 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 RESPONSIBILITIES • Contribute to the development and implementation of global CMC regulatory strategies for development, registration, and lifecycle management of combination products • Serve as the CMC Regulatory Affairs Combination Product and Device Lead for assigned device and combination product programs or workstreams • Interpret and apply relevant global regulations, guidance, and evolving expectations relevant to devices and combination products to program work and strategy • Provide regulatory input on device-related development activities, control strategy elements, design control documentation, and lifecycle changes needed to support regulatory submissions • Support 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 issues • Identify, communicate, and escalate regulatory risks or issues that may affect development, approval, or supply continuity • Support health authority interactions through preparation of background packages, responses to agency questions, and follow-up actions • Conduct regulatory impact assessments driven by lifecycle management of marketed combination products • Maintain current knowledge of regulatory trends for devices and combination products and communicate relevant updates to project teams • Support areas of priority to Gilead in policy/trade organization working groups for combination products • Contribute to process improvement and operational excellence initiatives within CMC Regulatory Affairs • Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities, as applicable

  QUALIFICATIONS • Undergraduate or advanced degree in life sciences or related field with significant CMC, manufacturing, device, development, regulatory, or related experience in the biopharma or related industry • 8+ years with BA/ BS • 6+ years with MA/ MS/ MBA • 2+ years with PharmD/ PhD

• Experience supporting development and submissions management of regulatory filings, including experience leading routine to moderately complex CMC regulatory activities • Working knowledge of global CMC regulatory requirements relevant to devices and combination products • Ability to interpret technical information and translate it into clear regulatory actions and plans • Strong collaboration, organizational, and project management skills • Strong verbal, written, and presentation skills • Demonstrated ability to work effectively across functions and influence without direct authority

  ABOUT GILEAD   Gilead 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: https://www.gilead.com/careers/compen

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