For Current Gilead Employees and Contractors:

　　Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

　　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.

　　We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

　　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. Join Gilead and help create possible, together.

　　Job Description

　　KEY RESPONSIBILITIES

　　The Senior Director, Affiliate Team Leader, CMC Regulatory Affairs International, leads and coaches a team of professionals responsible for registration of Gilead’s global commercial portfolio of products in Gilead affiliate markets in Canada, Hong Kong, Japan, Korea, and Singapore, where there is currently CMC RA presence. It is anticipated that the scope of this role will grow further moving forward as we expand our global presence in other locations. This team is an integral function in the CMC regulatory affairs organization which is part of the broader Pharmaceutical Development & Manufacturing (PDM) organization. This position will lead a team of CMC RA professionals in Gilead’s affiliates that ensures “right first time” global approvals of CMC regulatory submissions (new commercial marketing applications and clinical trial applications in Canada and Japan) and provides Gilead the “right to operate” by maintaining the global licensures. In addition, the Affiliate Team Leader will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, ICH regulations, and individual country requirements to assure timely approval in Gilead’s affiliate markets. The role will report directly to the Head of CMC Regulatory Affairs, International based in Cambridge, UK.

　　JOB DESCRIPTION

　　Lead a team of CMC RA professionals to support the registration and maintenance of commercial products in assigned international markets in Canada and Asia.

　　Partner with PDM to manage life-cycle maintenance aspects of international regulatory CMC submissions.

　　Act as the International CMC RA representative for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for assigned international markets.

　　Ensure/defend CMC dossiers to meet ICH content requirements, as well as consideration of the specific local requirements of individual countries.

　　Responsible for ensuring timely discussion with international health authorities regarding responses to questions and work with international colleagues to ensure consistency of responses (using ICH as the foundation).

　　Identify CMC risk areas for assigned markets and develop alternative courses of actions including anticipation of regulators responses through scenario planning and development of contingency plans.

　　Lead the execution of CMC regulatory plans for assigned markets, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, Gilead local country affiliates and third-party agents, and Project Management.

　　Lead/advise on regulatory strategies for assigned markets and solutions for complex CMC challenges for all Gilead product submissions and commercial registrations, including risk mitigation.

　　Ensure regulatory conformance and consistency for assigned products in assigned international markets in compliance with regulatory requirements and internal procedures.

　　Work (matrix) with the CMC RA Policy Office to proactively to build/maintain contacts with local Health Authorities, and to present a positive image of Gilead in all discussions with Health Authorities.

　　Maintain a current awareness of CMC registration requirements in each assigned market and communicate key regulatory intelligence to the organization on a timely basis.

　　Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity.

　　QUALIFICATIONS

　　A scientific degree with directly relevant professional experience in small molecule and/or biologics registrations, global CMC regulatory affairs, and CMC technical areas

　　Experience in the preparation of CMC components for clinical trial and/or new marketing applications or post-approval variation submissions for small molecule and/or biologics products.

　　Drug-device combination product experience would be an advantage, but not essential.

　　Experience with leading new product registration submissions and approvals, including Health Authority interactions.

　　Demonstrated success in influencing without positional authority within a highly matrixed organization.

　　An in-depth knowledge of ICH requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.

　　Application of sound and accurate judgment to make timely decisions.

　　Demonstrated success in leading groups to support operational goals and contribute to the development of global regulatory initiatives.

　　Demonstrated organizational leadership skills at functional level.

　　Excellent strategic acumen, collaboration, and communication skills are required.

　　Demonstrated commitment to inclusion, developing talent and empowering teams.

　　Gilead Core Values

　　Integrity (Doing What’s Right)

　　Inclusion (Encouraging Diversity)

　　Teamwork (Working Together)

　　Excellence (Being Your Best)

　　Accountability (Taking Personal Responsibility)

　　Equal Employment Opportunity (EEO)

　　It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

　　For Current Gilead Employees and Contractors:

　　Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

　　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.

　　Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

　　The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.