Manager, China CMC Regulatory Affairs

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Job Description

RESPONSIBILITIES:

* Develop and execute global regulatory strategies for assigned programs
* Collaborate with regional counterparts to compile and align global regulatory strategies
* Create and submit high-quality, compliant regulatory documents within defined timelines
* Manage regulatory submissions and maintain compliance for assigned programs
* Support health authority interactions and meetings related to assigned programs
* Ensure accurate, up-to-date reporting of program status and milestones globally
* Lead and mentor junior staff, enhancing team capabilities

R&D Qualifications & Skills:

* Expertise in developing regulatory strategies and a deep understanding of CMC requirements
* Proven ability to negotiate with and influence health authorities
* Strong leadership skills, capable of managing and directing project teams
* Effective at working across functions to align strategies and achieve objectives
* Skilled in managing regulatory submissions and maintaining compliance
* Excellent communication skills, able to clearly convey complex information
* Proficient in mentoring and developing junior staff, enhancing team capabilities
* Capable of identifying and mitigating risks in regulatory strategies and operations

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