About the job

• Job Title: Global Regulatory Lead CMC Type of Employment- Contract- Inside IR35Location: Remote (UK)Keywords: Change control Assessment/Evaluation, Regulatory requirements, variation classification, Regulatory CMC Strategies, Lifecycle management of submissions, Compile, review, and dispatch overall submission packageMarket Experience: EU, APAC, China, JapanJD for GRL CMC-Provide of 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 aspectsContract terms : Minimum – 1 HourMaximum – 150 hrsBilled on actual utilization