R&D - GRA - Regulatory Affairs Manager - BJ
On-siteBeijing, Beijing, China
Job Summary
Develop and implement regulatory strategies for I&I Alliance products in China, leading cross-functional teams to ensure timely Marketing Authorisations and manage lifecycle activities. Manage regulatory processes in compliance with internal standards and NMPA requirements, while coordinating with the China Business Unit and Global divisions to evaluate pathways and risks. Establish effective collaboration with the GRA team to maximize synergies, monitor new regulatory requirements, and communicate environment changes to stakeholders. Proactively share new product development status and align with GRL. Requires 8+ years of pharmaceutical regulatory experience in China, bilingual proficiency in Chinese and English, and strong project management skills.
Required Qualifications
- Bachelor's degree in Pharmacy, Medicine, Life Sciences or related field
- Minimum 8 years of regulatory affairs experience in the pharmaceutical industry
- Solid experience in China regulatory submissions
- Proficient in both Chinese and English with fluent communication skills (written and spoken)
- 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
Desired Qualifications
- Master's degree or above
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