Director CMC Regulatory Operations

J&J Family of Companies ,
High Wycombe, Buckinghamshire
More Details

Overview

Job Description

Director CMC Dossier Development + Support the regulatory activities related to Drug Products for the Company's Vaccines Therapeutic Area, including pre-and post-approval submissions in all global markets. + You will work within the Vaccines Process and Analytical Development department to support the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and content plans for lifecycle of the product(s) + Contribute to the preparation and editing of clinical trial and marketing applications + Support both Drug Development Teams and provide direction on the interpretation and application of global CMC regulations and guidances related to Vaccines + You will support the preparation of correspondence to Health Authorities regarding Vaccine Products + Provide technical review and approval of test protocols, reports and other source documents. + Work with CMC team to ensure that the VPAD's CMC strategies are aligned with CMC regulatory strategies and the Target Product Profile (TPP). + Work with RA CMC to ensure communication and alignment of the CMC regulatory strategy Qualifications Qualifications A Bachelor's degree with 10+ years of pharmaceutical or medical device industry experience OR a Master's degree with 8+ years of pharmaceutical or medical device industry experience OR a PhD with 6+ years of pharmaceutical or medical device industry experience is required. + A degree in Pharmacy, Chemistry, Biology or a related science/technical field is preferred. + At minimum of 5 years of experience in Regulatory Affairs is required + Direct experience in the preparation of sections (Module 3) in any one of the following submissions NDA/BLA/MAA is required + Previous experience managing directly/indirectly other people to manage in a matrix team environment is required. Primary Location United Kingdom-England-High Wycombe- Organization Janssen Cilag Ltd. (7360) Job Function R&D Requisition ID 2005829535W

People also viewed