Beijing, CHN
2 days ago
Manager, China CMC Regulatory Affairs
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 (https://jobs.takeda.com/privacynotice) and Terms of Use (https://www.takeda.com/terms-and-conditions/) . 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** Beijing, China **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time
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