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Manager, Regulatory Affairs - Shanghai, 中国 - Gilead Sciences Shanghai Pharmaceutical Technology Co., Ltd. Beijing Branch
描述
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.
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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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