Director, Regulatory Affairs CMC

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

• Responsible for leading all CMC regulatory activities for assigned project(s), in line with ICH requirements, regional requirements, scientific knowledge, and company policies and procedures.
• Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages.
• Actively collaborates with internal teams (including Technical Development, Manufacturing, Supply Chain and Quality) to identify and rank risks, propose risk mitigation plans, and execute robust CMC regulatory strategies.
• Leads CMC regulatory project teams and serves as core member of cross-functional PDM strategy teams.
• Ensures up-to-date knowledge of highly complex regulatory requirements, contributes to preparation of new regulatory guidances, comments on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management.
• Provides advice and drives decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs, and affiliates on internal meetings and leads global Health Authority interactions for CMC related topics.
• Initiates or contributes to local and/or global process improvements which have a significant impact on the business.
• Provides regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises.
• Coaches and mentors junior regulatory CMC RA staff.
• Contributes to update, maintain, and verify documents, submissions and registrational details in a validated Regulatory Information Management system.

• Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant industry experience or 10 + years of experience with a m aster's degree/advanced degree.
• Requires a bachelor’s degree in a relevant scientific discipline. An advanced degree is preferred.
• A proven track record of developing and leading global CMC regulatory submissions strategies and submissions in all phases of drug development, including life cycle management (IND, IMPD/CTA, NDA, MAA, etc.).
• Deep understanding of global regulatory requirements and guidelines.
• Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.
• Collaborative, proactive, and highly organized approach to work.
• Excellent verbal and written communication, negotiation and interpersonal skills.

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.