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

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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.

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