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