Sr Manager, Regulatory Affairs

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. Join Gilead and help create possible, together. Job Description RESPONSIBILITIES ▪ Focus primarily on Gilead’s inflammation and oncology therapeutic areas. ▪ Serve as Affiliate Regulatory Lead for assigned products, indications, or projects and develop and execute regulatory strategies. ▪ Ensure timely and compliant filing of regulatory dossiers including clinical trial applications, amendments, and other clinical trials submissions. ▪ Manage NDA/BLA applications, variations, and other lifecycle maintenance applications. ▪ Lead regulatory interactions with local HA, including preparation of meeting materials, responses to inquiries and follow-up activities. ▪ Monitor regulatory environment and competitor intelligence and contribute to preparation or update of new local regulatory guidance when applicable. ▪ Represent Regulatory Affairs in cross-functional teams and working groups. ▪ Contribute to continuous improvement initiatives, special projects, internal working groups. ▪ Assume systems responsibility for key regulatory systems. ▪ Provide regulatory support for promotional material review and ensure consistency with approved labeling. KNOWLEDGE, EXPERIENCE, AND SKILLS ▪ 8+ years’ experience in regulatory affairs, and experience in inflammation, immunology, oncology, or related therapeutic areas is highly preferred. ▪ Bachelor’s degree in pharmacy, Life Sciences or a related discipline; advanced degree preferred. ▪ Be flexible and proactive with strong team spirit. ▪ Demonstrated ability to manage multiple regulatory projects simultaneously and deliver high-quality results within agreed timelines. ▪ Ability to identify regulatory risks and propose mitigation strategies. ▪ Ability to influence cross-functional teams and drive alignment in a matrix environment. ▪ Excellent verbal and written English language skills and interpersonal communication skills required. 在吉利德，我们致力于为所有人创造一个更健康的世界。过往逾35年间，我们在HIV、病毒性肝炎、COVID-19、肿瘤等危及生命的疾病领域持续推动药物革新，改善患者生活，并在全球范围内提升药物可及。未来，我们将继续应对全球最具挑战的健康问题，为实现这一使命，需要我们同心协力、坚定信念和不懈努力。 每个你，都将在我们探索和推动改变生命的科学创新进程中扮演至关重要的角色，“吉客”是我们得以实现伟大愿景的重要伙伴，我们期待充满热忱、志存高远的你，在这里创造真正的影响力。 我们深信卓越的管理者才能赋能卓越的团队，每一位吉利德领袖都致力于为“吉客”创造积极的工作体验。无论你现在、抑或有志向成为团队管理者，都是塑造“吉客文化”的关键“引擎”，让我们共同创造一个让每位“吉客”都能感受到包容、持续成长和充分赋能的职场环境，实现未来无限可能。 加入吉利德科学，携手，突破不可能！ 岗位职责 · 负责吉利德炎症及肿瘤治疗领域相关项目。 · 负责制定产品、适应症或项目的注册策略并执行。 · 负责临床试验申请、临床变更申请及其他临床试验相关注册资料的按时合规递交。 · 负责新药上市申请、变更申请以及产品全生命周期维护相关的注册事务。 · 负责与中国药品监管机构的沟通交流，包括会议资料准备、问题回复及后续跟进工作。 · 持续跟踪监管政策动态及竞品信息，并在适当情况下参与公司法规操作指南的制定和更新。 · 代表注册事务部门参与跨职能部门会议及内部工作组会议。 · 参与持续改进举措、专项项目及内部工作组工作，助力部门运营效率和业务能力持续提升。 · 负责关键注册系统的管理与维护工作。 · 为推广材料审阅提供注册支持，确保其与已批准说明书内容保持一致。 知识、经验与技能要求 · 具有8年以上注册事务相关工作经验；具备炎症、自身免疫、肿瘤或相关治疗领域经验者优先。 · 药学、生命科学或相关专业本科学历；硕士或更高学历优先。 · 具备良好的适应能力和主动性，具有较强团队合作精神。 · 具备同时管理多个注册项目的能力，能够在约定时间内高质量完成工作任务。 · 能够识别注册风险，并提出有效的解决措施。 · 具备在矩阵式组织架构下影响跨职能团队并推动达成一致意见的能力。 · 具备优秀的英语口头和书面表达能力，以及良好的人际沟通能力。 For Current Gilead Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.