Takeda Pharmaceutical fa jobs (salary & requirements)

• With minimal supervision, executes manages regulatory submission fassigned projects.
• With supervision, prepares CMC submission dossier, helps define CMC content requirements, ensure high quality CMC submission complying with external internal requirement.
• With supervision, participates Health Authority interactions 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 timely manner.
• Evaluates change proposals fregulatory impact with supervision, helps plan variations amendments.
• Ensure compliance with all applicable Takeda SOPs, local international regulations.
• BS/BA Degree required with 4+ years of relevant Industry, academic HA experience; advanced degree preferred
• Experience with CMC regulatory regulatory, equivalent industry experience.
• Ability to understand, apply articulate regulatory CMC requirements fdrug development post-market support initiatives required.
• Demonstrates attention to detail problem-solving abilities.
• Exercise appropriate judgement when working with project teams.
• Excises good judgement in elevating communicating actual potential issues to line management.
• Excellent writtenal communication skills required.