CASY-MSCCN Jobs

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site 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

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.

KEY RESPONSIBILITIES

The Associate Director, CMC Regulatory Affairs – China is responsible for developing Gilead’s China global portfolio and maintaining Gilead’s China marketed products in CMC Regulatory Affairs, which is part of the broader Pharmaceutical Development & Manufacturing (PDM) organization. This position will develop CMC strategy for assigned projects that ensures “right first time” global approvals of CMC regulatory submissions (clinical and commercial), and “right to operate” by maintaining the global licensures. In addition, the position will be accountable for leading the interpretation and implementation of CMC regulatory guidelines, ICH, regulations, and current environment to assure approvability in China. The role will report directly to the Head of CMC Regulatory Affairs, China.

JOB DESCRIPTION

• Partner with China Regulatory Affairs team to develop and implement CMC strategy for assigned products/projects entering in/or established in China (clinical and commercial).

• Partner with central CMC Regulatory Affairs team to lead development and life cycle management aspects of China regulatory CMC submissions.

• Ensure/defend CMC dossiers to meet ICH content requirements, as well as the specific local requirements.

• Take a regional leadership position in conducting China-specific risk assessments on global CMC regulatory tasks and provide guidance to corporate management.

• Responsible for ensuring timely discussion with China authorities regarding responses to questions and work with central CMC RA team to ensure consistency of responses.

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

• Lead the execution of the China CMC regulatory plans for assigned projects, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.

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

• Ensure regulatory conformance and consistency for assigned products in China in compliance with regulatory requirements and internal procedures.

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

QUALIFICATIONS

• A scientific degree in life sciences or pharmaceutical sciences with directly relevant professional experiences in biologics and chemical drugs CMC development, registration, or CMC technical areas of at least 10 years with a BS or 6 years with an MS, PhD, PharmD, or MD.

• Demonstrated track record in defining innovative CMC regulatory strategies and implementing at a platform level.

• Experiences with leading NDA/BLA submission and approval, e.g., therapeutic antibody, major CMC variations submission and approval, including direct CDE/NIFDC technical interactions.

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

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

• Application of sound and accurate judgment to make timely decisions.

• Demonstrated success in leading project team to support operational goals and contribute to the development and implementation of regulatory submission plan.

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

• Demonstrated commitment to inclusion, collaboration, and teamwork.

• Preferred to have working experiences at health authorities.

• Fluent in spoken and written English.

• Located in Beijing or Shanghai.

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

主要职责：

中国CMC 法规事务副总监 - 负责开发吉利德在中国的全球产品组合，并维护吉利德在中国销售产品的 CMC 法规事务。CMC RA 是吉利德药物开发与制造组织(PDM)的一部分。 该职位将为指定项目制定 CMC 策略，确保 CMC 监管提交（临床和商业）的“首次正确”全球批准，并通过维护全球许可来合理运营。 此外，该职位还将负责领导 CMC 监管指南、ICH、法规和监管实操的解释和实施，以确保在中国的批准。 该职位将直接向中国CMC RA负责人汇报。

职位描述：

• 与中国法规事务团队合作，为准备开发/或已在中国上市的指定产品/项目（临床和商业）制定和实施CMC 策略。

• 与总部CMC 法规事务团队合作，领导中国CMC 资料提交的开发和生命周期管理工作。

• 确保/捍卫CMC 档案以满足ICH 内容要求以及特定的当地要求。

• 在针对全球CMC 法规活动开展针对中国的风险评估方面发挥领导作用，并为企业管理层提供指导。

• 负责确保及时与中国监管机构就问题答复进行讨论，并与总部CMC 法规事务团队合作以确保答复的一致性。

• 确定中国CMC 注册的风险领域并制定替代行动方案，包括通过情景规划和制定应急计划来达成监管机构要求。

• 领导执行指定项目的中国CMC注册计划，包括与PDM、法规事务和临床开发等其他职能部门密切合作，监督递交和审批流程。

• 针对指定的吉利德产品递交和商业注册的复杂CMC 挑战，领导/提供建议，包括排除风险在内的中国注册策略和解决方案。

• 确保指定产品在中国的监管合规性和一致性，符合监管要求和内部程序。

• 展示和示范吉利德的核心价值观和领导力承诺；拥护并遵守全球 CMC 诚信原则。

任职要求：

• 拥有生命科学或制药科学学位，在生物制品和化学药物 CMC 开发、注册或 CMC 技术领域拥有至少 10 年（学士学位）或 6 年（硕士、博士、药学博士或医学博士）直接相关的专业经验。

• 在开发创新CMC 注册策略和在平台层面上实施方面具有良好的记录。

• 拥有领先的 NDA/BLA 提交和批准经验，例如治疗性抗体、重大 CMC 变更提交和批准，包括直接 与CDE/NIFDC的技术互动。

• 在高度矩阵化的组织中展现出在没有隶属关系的情况下成功发挥影响力的能力。

• 深入了解ICH 要求，并了解CMC 注册事务的当前全球趋势。

• 运用合理而准确的判断来及时做出决策。

• 在领导项目团队支持运营目标并为注册递交计划的制定和实施做出贡献方面取得了成功。

• 需要出色的战略敏锐度、协作和沟通技巧。

• 表现出对包容、协作和团队合作的承诺。

• 有监管部门工作经验者优先。

• 英语口语和书写流利。

• 工作地点可在北京或上海。

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site 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.