(Sr.)Manager, CMC Regulatory Affair, R&D, ShanghaiBeijing

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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