Associate Director, CMC Regulatory Affairs Biologics
4 weeks ago
Position 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 Whats 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 ApplicantAccommodations@gilead.com. 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. Job Level: Associate Director. #J-18808-Ljbffr
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