R&D - GRA - Regulatory Affairs Manager - BJ

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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