Director, CMC Regulatory Affairs- Biologics

Director, CMC Regulatory Affairs- Biologics

Job Description

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.Director, CMC Regulatory Affairs – BiologicsKey Responsibilities:Lead CMC regulatory strategy for a single or multiple products.Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of product submissions.Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.Responsible for development of regulatory strategies and solutions for complex CMC challenges for clinical or commercial projects.Responsible for interpretation and implementation of ICH and other global guidelines with a goal of an approved/ harmonized regulatory control strategy.Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead.Lead CMC strategies, assess risks, and develop contingency plans, including major, complex applications.Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity.Minimum Qualifications:A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.Demonstrated track record in executing and implementing CMC regulatory strategies for a given molecule.Knowledge of global CMC regulatory landscape.Application of sound and accurate judgment to make timely decisions.Ability to demonstrate strategic acumen and collaboration.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)

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