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.
