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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
 

We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster City, CA site.

Responsibilities:

The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiativesResponsible 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 proceduresWork collaboratively with cross functional matrix teams to develop a CMC submission plan in accordance with business objectivesActively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners and CROs) to develop and execute robust CMC regulatory strategiesProvides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidanceLead the preparation of risk assessments on major global CMC regulatory issuesProvides regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises.Coordinates and facilitates development of Regulatory CMC strategies with development and commercial project teams, affiliates for local meetings and interactionsProven ability to remain current on CMC regulatory intelligence including guidelines and regulatory trends, and to drive and implement strategic policy decisionsLeads 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 kept apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely mannerInitiates process improvements, contributes to global process improvements, and support the development and maintenance of regulatory templates, best practices, and procedures.Coach and mentor junior regulatory CMC RA staff

Qualifications:

Requires a Bachelor's degree in a relevant scientific discipline and 10+ years of experience OR (Preferred) Requires a Masters degree in a relevant scientific discipline and 8+ years of experience OR(Preferred) Requires a PhD in a relevant scientific discipline and 5+ years of experienceCandidate must have relevant experience in Regulatory Affairs CMC or other relevant industry experience. Experience in scientific/ technical field is preferred.A proven track record of developing global CMC strategies in all phases of drug development including life cycle management Collaborative, proactive, and highly organized approach to workDemonstrated track record with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC Regulatory activities and initiativesDeep understanding of global regulatory requirements and guidelinesExcellent communication and interpersonal skills

 

The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
 

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.