About this role
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Job Description
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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND 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.
Locations CHN - Shanghai - Research and DevelopmentCHN - Beijing - Research and Development Worker Type Employee Worker Sub-Type Regular Time Type Full time