Role at a glance
- Job function
-
Legal & Compliance Compliance & Regulatory Affairs
- Salary
- Not Disclosed
- Location
- CHN, Shanghai, Research and Development
- Work arrangement
- On-site
- Employment
- Full-time
- Education
- Bachelor's
Spotted an issue?
We’ll check it against the original posting.
About the role
Original posting provided by Takeda
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 time
About the company
Takeda
Large Enterprise
Takeda is a global biopharmaceutical company headquartered in Tokyo, Japan, with a rich history spanning over 240 years. Specializing in the research, development, and commercialization of innovative medicines, Takeda focuses on therapeutic areas such as oncology, gastroenterology, neuroscience, and rare diseases. Committed to improving patient outcomes, the company harnesses advanced technologies and scientific expertise to deliver breakthrough therapies and enhance healthcare worldwide. Takeda's dedication to sustainability and social responsibility underscores its mission to strive towards better health for people and communities across the globe.