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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.
CHN - Shanghai - Research and DevelopmentCHN - Beijing - Research and Development
Employee
Regular
Full time
We strive to transform lives. While the science we advance is constantly evolving, our core purpose is enduring. For more than two centuries, our values have guided us to do what’s right for patients and for society.
We know that changing lives requires us to do things differently. We start by listening to and addressing what really matters to patients, the people who love them, and those in the healthcare system who provide care. And that’s what inspires us all to be bold, push boundaries and set new standards that open up greater opportunities.
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