(Sr.)Manager, CMC Regulatory Affair, R&D, ShanghaiBeijing
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Job Summary
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ACCOUNTABILITIES
With minimal supervision executes and manages regulatory submission for assigned projects.
With supervision prepares CMC submission dossier helps define CMC content requirements ensure high quality CMC submission complying with external and internal requirement.
With supervision participates Health Authority interactions and support CMC consultation meetings preparation with Health Authority on CMC related matters.
With moderate supervision handle sample registration testing in NIFDC/IDC to support related registration approval.
With moderate supervision support Health Authority on-site inspection on CMC RA related matters.
Ensure line management is apprised of developments that may impact regulatory success communicating in professional and timely manner.
Evaluates change proposals for regulatory impact with supervision and helps plan variations and amendments.
Ensure compliance with all applicable Takeda SOPs and local and international regulations.
R&D Qualifications & Skills
BS/BA Degree required with 4 years of relevant Industry academic or HA experience; advanced degree preferred
Experience with CMC regulatory and regulatory or equivalent industry experience.
Ability to understand apply and articulate regulatory CMC requirements for drug development and post-market support initiatives required.
Demonstrates attention to detail and problem-solving abilities.
Exercise appropriate judgement when working with project teams.
Excises good judgement in elevating and communicating actual or potential issues to line management.
Excellent written and oral communication skills required.
Required Experience:
Manager
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
