(Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing

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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