位于北京市, c22的 4 个优质head of职位（正在招聘！）

R&D - GRA - Regulatory Affairs Manager - BJ
Sanofi —北京市
- 合同工
9天
McQueen Client Advisor
Alexander McQueen —北京市
Sales Manager (China)
Swaarm Tech GmbH —北京市
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Senior Director, Corporate Communication, Greater China
Visa Information Systems (Shanghai) Co., Ltd., Beijing Branch —北京市

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McQueen Client Advisor
Alexander McQueen —北京市
Provide exceptional client experience by greeting, listening and assisting clients in exceeding their needs, demonstrating an excellent knowledge of the…

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R&D - GRA - Regulatory Affairs Manager - BJ

Sanofi -
北京市

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职位详情

合同工
9 天前

完整职位描述

Job Title: Regulatory Affairs Manager, I&I Alliance

Reports to: TA Head, I&I Alliance, China

Team Management: Individual Contributor

Key Responsibilities:

China – I&I Alliance

Support the development and implementation of appropriate regulatory strategies for I&I Alliance products in China, under the guidance of the TA Head.
Lead cross-functional teams to ensure timely submission and delivery of Marketing Authorisations in China in line with agreed strategy, and manage the consequent lifecycle management activities.
Manage regulatory processes effectively and in compliance with internal standards and regulatory requirements, ensuring appropriate dossier quality for submissions and overall regulatory compliance in China.
Establish effective coordination of regulatory activities in China, supporting cooperation with the China Business Unit and Global divisions.
Work across project teams to evaluate regulatory pathways, risks, and timelines for assigned I&I Alliance products.
Build effective collaboration with the GRA (Global Regulatory Affairs) team to maximize synergies in regulatory activities.
Monitor and adopt new regulatory requirements and Group standards to ensure ongoing regulatory compliance in China.
Communicate regulatory environment changes to relevant stakeholders and proactively anticipate future trends.
Lead cross-functional collaboration to provide necessary regulatory support for I&I Alliance products.
Proactively share new product development status and get alignment with GRL in a timely manner.

Qualifications & Requirements

Education Bachelor's degree required in Pharmacy, Medicine, Life Sciences or related field; Master's degree or above preferred

Experience Minimum 8 years of regulatory affairs experience in the pharmaceutical industry, with solid experience in China regulatory submissions

Language Proficient in both Chinese and English with fluent communication skills (written and spoken)

Skills Strong project management and cross-functional coordination skills; ability to lead submission teams without direct authority; good understanding of NMPA requirements and global regulatory frameworks

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在北京市, c22的head of个职位

R&D - GRA - Regulatory Affairs Manager - BJ

McQueen Client Advisor

Sales Manager (China)

Senior Director, Corporate Communication, Greater China

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在北京市, c22的head of个职位

McQueen Client Advisor

Sales Manager (China)

Senior Director, Corporate Communication, Greater China

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