Manager, China CMC Regulatory Affairs
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Job Location:
Monthly Salary:
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
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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
Beijing ChinaWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRequired Experience:
Manager
Key Skills
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
