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

Takeda

  • Beijing Shanghai
  • Permanent
  • Full-time
  • 16 days ago
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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionRESPONSIBILITIES:
  • 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, ChinaWorker Type EmployeeWorker Sub-Type RegularTime Type Full time

Takeda