Senior Manager, Regulatory Affairs CMC

For Current Gilead Employees and Contractors:

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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.

Job Description
 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than

35 countries worldwide, with headquarters in Foster City, California

About the role:

The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for

CMC regulatory activities and related regulatory initiatives.

Responsibilities:

• Responsible for preparing and/or overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products in line with ICH requirements, regional requirements, and scientific and company policies and procedures

• Work collaboratively with cross functional matrix teams to develop a CMC submission plan in accordance with business objectives

• Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategies

• Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance

• Evaluates change proposals for global regulatory impact and plans global amendments

• Coordinate and facilitate development of Regulatory CMC strategy with development teams, affiliates for local meetings and interactions

• Ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisions

• Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments)

• Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner

• Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams

• Coach and mentor junior regulatory CMC staff

Minimum Qualifications:

• Have 8+ years of experience in Regulatory Affairs CM