Shanghai, CHN
1 day ago
(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** Shanghai, ChinaBeijing, China **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time
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