IntelStack
Global Regulatory Lead CMC
United Kingdom
Posted 1 day ago
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Job Title: Global Regulatory Lead CMC
Type of Employment
- Contract - Inside IR35
Location
- Remote (UK)
Keywords
- Change control Assessment/Evaluation
- Regulatory requirements
- Variation classification
- Regulatory CMC Strategies
- Lifecycle management of submissions
- Compile, review, and dispatch overall submission package
Market Experience
- EU
- APAC
- China
- Japan
JD for GRL CMC
- Provide regulatory evaluation of change control (data/documentation requirements and regulatory strategy (RAAT (Regulatory Impact Assessment)))
- Review documentation and dispatch final documentation package to Local Regulatory Affairs
- Monitor timely submission and approval of variation packages, renewals and CMC commitment, Manage and coordinate responses to health authority questions
- Overall planning of all CMC regulatory changes per product together with relevant interfaces, G CMC RA in cross-functional teams
- Provide regular progress reports and updates
- Provide regulatory requirements and regulatory strategy for post approval changes or tasks in Regulatory processes with special emphasis on CMC aspects
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Contract terms
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- Maximum – 150 hrs
- Billed on actual utilization
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Skills
Change Control Assessment
Regulatory CMC Strategies
Lifecycle Management
Variation Classification
Regulatory Impact Assessment
Submission Package Compilation
Health Authority Response Management
Post-approval Changes
Location