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RESPONSIBILITIES:
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Develop and execute global regulatory strategies for assigned programs
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Collaborate with regional counterparts to compile and align global regulatory strategies
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Create and submit high-quality, compliant regulatory documents within defined timelines
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Manage regulatory submissions and maintain compliance for assigned programs
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Support health authority interactions and meetings related to assigned programs
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Ensure accurate, up-to-date reporting of program status and milestones globally
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Lead and mentor junior staff, enhancing team capabilities
R&D Qualifications & Skills：
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Expertise in developing regulatory strategies and a deep understanding of CMC requirements
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Proven ability to negotiate with and influence health authorities
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Strong leadership skills, capable of managing and directing project teams
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Effective at working across functions to align strategies and achieve objectives
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Skilled in managing regulatory submissions and maintaining compliance
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Excellent communication skills, able to clearly convey complex information
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Proficient in mentoring and developing junior staff, enhancing team capabilities
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Capable of identifying and mitigating risks in regulatory strategies and operations
Shanghai, ChinaBeijing, China
Employee
Regular
Full time
