Assoc Director, Regulatory Affairs CMC

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.

Job Description

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

Responsibilities

- Responsible for leading all CMC regulatory activities and strategy development for assigned project(s), in line with ICH requirements, regional requirements, scientific knowledge, and company policies and procedures.
- Actively collaborates with internal teams (including Technical Development, Manufacturing, Supply Chain and Quality) to identify and rank risks, propose risk mitigation plans, and develop/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 Gilead 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.

Specific Education & Experience Requirements:

- 10+ years of experience in CMC Regulatory Affairs (CMC RA) or other relevant industry experience (8+ with 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 strategies and submissions (IND, IMPD/CTA, NDA, MAA, etc) in all phases of drug development, including life cycle management.
- Deep understanding of global regulatory requirements and guidelines.
- Collaborative, proactive, and highly organized approach to work. Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment. Excellent verbal and written communication, negotiation and interpersonal skills.

People Leader Accountabilities:

- 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

Gilead is an equal opportunity employer and complies with all applicable laws and regulations regarding employment practices.

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