Director – CMC Regulatory Affairs – Biologics

Director – CMC Regulatory Affairs – Biologics

Requirements

• 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.

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.

Preferred Qualifications

No preferred qualifications provided.