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R&D - GRA - Senior Regulatory Affairs Manager - BJ

北京, 中国 Fixed Term (Fixed Term) 发布于   Apr. 29, 2026 申请截止于   Jun. 30, 2026
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Regulatory strategy establishment for new vaccines and the regulatory strategy implementation by CTA / NDA submission / approval.

●      Work with GRA and across project team to develop and implement the regulatory strategy of the responsible projects, aligned with global strategy and regional business strategy. (Dossier preparation, gap assessment, regulatory pathway and timelines, RA compliance, Implication of the findings on the deal terms, ways to mitigate identified risks, implications on cost / time etc.)

●      Regulatory supports for the related submissions in China region

●      Collaborate with related functiona at corporate, IA and project team to support the regulatory activities in China region.

●      Effective interaction with Health Autorities.

●      Lead the cooperative projects related to shaping of registration regulatory environment.

●      Lead and coordinate the HA interaction and cross-functional discussion & contribution.

●      Provide RA inputs

●      Move forward the projects in agreed timetable.

●      Provide RA supports on vaccine China business

●      Work with related functions in China to provide RA support on business timely.

●      Update key changes in regulations and their implications

●      Inputs for strategic projects on RA regulations, requirements, trends.

●      Ensure regulatory compliance and work in compliance way

Job Family Group: Regulatory Affairs - Center of Expertise

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进步需要我们每个人的参与——不论其背景、地域、或职业，我们都有一个共同的愿望：创造奇迹。你也可以成为其中的一员。我们不断追求变革，拥抱新思想，探索我们所能提供的一切机会。让我们一起追求进步。共同发现非凡。

在赛诺菲，不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同，我们为所有人提供平等的机会。

观看 “在赛诺菲的一天” ，并在官网 (sanofi.com) 上查看赛诺菲的多元化、公平与包容倡议！

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