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

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.

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

Worker Type

Worker Sub-Type

Time Type