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Job Description

RESPONSIBILITIES:

Develop and execute global regulatory strategies for assigned programsCollaborate with regional counterparts to compile and align global regulatory strategiesCreate and submit high-quality, compliant regulatory documents within defined timelinesManage regulatory submissions and maintain compliance for assigned programsSupport health authority interactions and meetings related to assigned programsEnsure accurate, up-to-date reporting of program status and milestones globallyLead and mentor junior staff, enhancing team capabilities

R&D Qualifications & Skills：

Expertise in developing regulatory strategies and a deep understanding of CMC requirementsProven ability to negotiate with and influence health authoritiesStrong leadership skills, capable of managing and directing project teamsEffective at working across functions to align strategies and achieve objectivesSkilled in managing regulatory submissions and maintaining complianceExcellent communication skills, able to clearly convey complex informationProficient in mentoring and developing junior staff, enhancing team capabilitiesCapable of identifying and mitigating risks in regulatory strategies and operations

LocationsShanghai, ChinaBeijing, China

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time