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 capabilitiesR&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...