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Manager, Regulatory Affairs - Beijing, 中国 - Gilead Sciences
描述
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.
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
RESPONSIBILITIES
Focused primarily on Gilead's oncology therapeutic area.
Responsible for providing regulatory inputs and supports relevant to assigned topics, products and/or projects, such as providing inputs into cross-functional clinical development programs.
Typically assigned responsibilities as Affiliate Regulatory contact person on multiple products or projects.
Timely and compliant filing of regulatory dossiers including clinical trial applications, amendments, and other clinical trials submissions.
Responsible for NDA/BLA applications, variations, and other lifecycle maintenance applications.
Responsible for documents preparation and submission for pre-IND meeting, pre-NDA meeting, RTQ, etc.
May represents Regulatory Function at internal and external meetings or working parties.
May responsible ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.
Actively participate in internal working groups, and assuming systems responsibility for key regulatory systems.
Maintains up to date knowledge of highly complex regulatory requirements, contributes to preparation/discussion of new local regulatory guidance when applicable.
Closely monitor report relevant changes to local requirements and competitor regulatory information to global RA, Regulatory Intelligence, and the local Affiliate.
Representing regulatory and contributing to the brand cross-functional team, conducting promotional material review, and ensuring core claims are compliant with the license.
KNOWLEDGE, EXPERIENCE, AND SKILLS
5-8 years' experience in regulatory affairs; bachelor and/or master's degree. Pharmaceutical relevant major is preferred.
Familiar with registration regulation requirements including ICH and regional requirements.
Experiences in working project teams.
Capable of developing and implementing regulatory initiatives and managing negotiations with Health Authority.
Excellent verbal and written English language skills, organization skills and interpersonal communication skills required.
For jobs in the United States:
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For jobs in France:
Conformément à la Loi « Informatique et Libertés » (06/01/78), nous vous informons du fait que les données personnelles renseignées pourront faire l'objet d'un traitement informatique par Gilead et pourront être transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accès, de rectification et de suppression des données vous concernant. Vous pouvez exercer ce droit en contactant:
Job Title (Translated)
注册事务经理
Job Description (Translated)
职责 主要负责肿瘤治疗领域的注册事务工作 为负责的相关产品和项目提供注册建议,例如在临床试验开发阶段的跨部门合作项目提供注册建议 为本地相关部门或总部注册团队提供注册方面的建议 支持或负责临床试验申请及其变更等注册申报资料的准备,递交和跟进等工作 支持或负责药品上市许可、变更申请、再注册等注册申报资料的准备,递交和跟进等工作 负责药品临床申请或上市申请前与监管机构沟通交流会议的资料准备和递交,以及过程中的跟进和问题回复 如有需要,代表注册事务部门参加相关内部和外部的会议或工作组并提出建议 如有需要,负责短期或特别项目以持续提高注册事务相关能力 积极参与和注册相关工作流程提升相关的内部工作组,并充分评估流程改变带来的影响 与时俱进并能理解注册相关法规的要求,积极参与到法规和指南建立的讨论过程中 紧密跟进本地法规变化,并及时向总部和本地相关部门更新重大的法规变更以及竞品信息 代表注册事务部门进行产品市场推广材料审核和批准,并确保所审核的内容与所有获批信息保持一致 知识、经验和技能 5-8年注册行业相关工作经验;具备学士学位或研究生学位,药学领域相关专业优先 理解制药/生物技术行业的药品注册要求,包括 ICH要求和区域要求 有跨部门合作的项目经验 对国内或其它地区监管机构人员组成、系统和相关流程有深入了解 需要出色的口头和书面英语语言技能,组织能力和人际沟通能力
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