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