Plasma Center - EMT-P
takeda
(Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing
takeda· CHN - 2776 Commercial - Takeda (China) Holdings Co., Ltd
About this role
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.
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 DevelopmentWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeFrequently Asked Questions
Is the salary disclosed for the (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing position at takeda?
The salary for this (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing role at takeda is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing position at takeda located?
This (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing role at takeda is based in CHN - Beijing - Research and Development, CHN - Shanghai - Research and Development. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing role at takeda full-time or part-time?
This is listed as a Full time position. It is posted as a (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing role in the CHN - 2776 Commercial - Takeda (China) Holdings Co., Ltd department at takeda.
Which team or department does the (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing at takeda belong to?
This (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing position is part of the CHN - 2776 Commercial - Takeda (China) Holdings Co., Ltd department at takeda. See the full job description for more information about the team structure and responsibilities.
How do I apply for the (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing position at takeda?
Click the "Apply Now" button on this page. You will be redirected to takeda's official application portal hosted on workday where you can submit your application directly.
When was the (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing job at takeda posted?
This (Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing position at takeda was posted on Sep 7, 2026. Apply as soon as possible — early applications are often reviewed first.
(Sr.)Manager, CMC Regulatory Affair, R&D, Shanghai/Beijing
takeda
You'll be redirected to takeda's official application page on Workday.