Regulatory CMC Manager

This is an exciting opportunity to support a Pharmaceutical companies global regulatory affairs activities focusing on CMC.This is a On-site role, in Germany requiring English language skills, see below for mor information:Manage and oversee regulatory post approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:Provide of regulatory evaluation of change controls and regulatory strategyMonitor timely submission and approval in affected countriesManage and coordinate responses to health authority questionsOverall planning of all CMC regulatory changes per product together with relevant interfacesAuthoring of Dossier sections – Module 2 and Module 3 – DS and DPCompilation of CMC documents for MAA, renewals, variations, commitments,Interaction and cooperation with experts from the relevant departments and CMOs, also in non-European countries, to compile the information and data required for Module 3.2.P.Interaction with competent authorities in the context of ASMF/DMF and CEP activities.Minimum Qualifications:Bachelor\’s degree required in for Pharmaceutical: science, engineering, or related field6 or more years in Regulatory CMC Lifecycle managementEnglish + German language skills (Business Proficient)Experience with national and global regulatory affairs activities.Experience in small molecules and biological products.