Associate Director, CMC Regulatory Affairs
7 days ago
Position Please read the following job description thoroughly to ensure you are the right fit for this role before applying. Associate Director, CMC Regulatory Affairs – Biologics Overview Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. We focus on HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. We seek to improve patient care worldwide and collaborate to achieve bold ambitions. We value leadership, inclusion, and accountability. As a member of Gilead, you contribute to creating possible, together. KEY RESPONSIBILITIES Lead CMC regulatory strategy for one or more products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation to ensure right first-time product submissions. Oversee the execution of global CMC regulatory plans, coordinating with PDM, Regulatory Affairs, and Clinical Development to manage submissions and approvals. Develop regulatory strategies and solutions for complex CMC challenges for clinical or commercial projects. Interpret and implement ICH and other global guidelines to achieve an approved/harmonized regulatory control strategy. Collaborate across CMC Regulatory Affairs, PDM, and other functional groups within Gilead. Lead CMC strategies, assess risks, and develop contingency plans for major, complex applications. Demonstrate Gilead Core Values and People Leader Accountabilities, upholding global CMC principles of integrity. QUALIFICATIONS A scientific degree with at least 10 years of relevant experience in biologics development, global CMC regulatory affairs, and CMC technical areas (BA/BS) or 8+ years with an advanced degree (MA/MS, PhD, PharmD, or MD). Proven track record in executing and implementing CMC regulatory strategies for a molecule. Knowledge of the global CMC regulatory landscape. Judgment to make timely decisions; strong strategic acumen and collaboration skills. Advanced communication and presentation skills. GILEAD CORE VALUES Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Salary range: $182,070.00 – $235,620.00. Compensation is based on experience, qualifications, and geographic location. Benefits may include bonus eligibility, stock-based incentives, paid time off, and a benefits package including medical, dental, vision, and life insurance. See for details. For jobs in the United States Gilead is an equal employment opportunity employer. Employment decisions are made without regard to race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity or expression, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants with disabilities. For accommodations, contact Other notices: Know Your Rights poster; pay transparency; and related protections apply where applicable. For current Gilead employees and contractors: Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0047307. Full Time/Part Time: Full-Time. xmcpwfu Job Level: Associate Director. J-18808-Ljbffr
-
Associate Director, CMC Regulatory Affairs
7 days ago
Foster, CA, United States Gilead Sciences, Inc. Full timeAssociate Director, CMC Regulatory Affairs – Biologics Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. We focus on HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. We seek to improve patient...
-
Associate Director, CMC Regulatory Affairs
7 days ago
Foster, CA, United States Gilead Sciences, Inc. Full timePosition Associate Director, CMC Regulatory Affairs – Biologics Overview Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. We focus on HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. We seek to...
-
Associate Director, CMC Regulatory Affairs
7 days ago
Foster, CA, United States Gilead Sciences, Inc. Full timePosition Associate Director, CMC Regulatory Affairs – Biologics Overview Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. We focus on HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. We seek to...
-
Associate Director, Regulatory Affairs CMC
1 week ago
Foster, CA, United States Gilead Sciences, Inc. Full timeAssociate Director, Regulatory Affairs CMC Job Description We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site. Responsibilities: The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational support, and technical expertise for CMC...
-
Director, CMC Regulatory Affairs
1 week ago
San Francisco, United States Larimar Therapeutics Full timeDescription:About Us:Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein...
-
Foster, CA, United States Gilead Sciences, Inc. Full timePosition Associate Director, CMC Regulatory Affairs Biologics Overview Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes medicines in areas of unmet medical need. We focus on HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. We seek to...
-
Regulatory Affairs CMC Associate
2 weeks ago
San Diego, CA, United States Katalyst CRO Full timeResponsibilities Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology, HIV and liver disease. The Associate, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities. May serve as...
-
San Francisco, CA, United States Valid8 Financial, Inc. Full timeDirector / Senior Director, Regulatory Affairs (Clinical & CMC) Regulatory The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to enable the development of our therapeutics. This individual will oversee both Clinical and CMC regulatory functions, providing strategic and operational leadership...
-
San Francisco, CA, United States Valid8 Financial, Inc. Full timeDirector / Senior Director, Regulatory Affairs (Clinical & CMC) August 2025 Department: Regulatory For a complete understanding of this opportunity, and what will be required to be a successful applicant, read on. The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to enable the development of our...
-
San Francisco, CA, United States Valid8 Financial, Inc. Full timeDirector / Senior Director, Regulatory Affairs (Clinical & CMC) August 2025 Department: Regulatory Position Summary: The Director/Senior Director, Regulatory Affairs will lead and execute global regulatory strategy and operations to enable the development of our therapeutics. This individual will oversee both Clinical and CMC regulatory functions, providing...
