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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
Locations
Shanghai, ChinaBeijing, China
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time