Takeda
(Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing
China · Work style not stated · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerTakeda
- LocationChina
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
Show full description
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.
R&D Qualifications & 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
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At a glance
- Employment typeFull time
- SenioritySenior
- Employer posted
- Added to ROLIVA
- Last checked