Assistant General Manager

Major purpose of the Job: Overall responsibility for submission and approval of marketing authorization applications in ICH regions- EU, UK, AUS, NZ, CA.Responsibilities: Review of eCTD dossiers/renewal applications/variations/any other post marketing applications for ICH regions- EU, UK, AUS, NZ, CA. Managing the response of deficiencies for ICH regions with timely initiation and discussion with cross-functional teams. Provide regulatory strategy, guidelines and support to the cross-functional teams (RnD, Manufacturing, QA, QC ISBU). Take up feasibility assessment for projects proposed by ISBU for ICH markets, as required. Collaborative interaction with clients and attending meetings for ongoing projects. Attend internal project management meetings for on-going projects. Liasioning with the regulatory agencies for clarifications/updates required for the submitted applications. Plan, prioritize and allocate the projects to the team. Review and approve technical documents from cross-function teams related to registrations / submissions / variations- spec/STPs, protocols/reports, MMD-I, labelling/artwork etc. Review and approval of change controls, deviations, MMD-II, MDM, SAP orders as required. Keeping abreast with the development status of pipeline projects. Tracking and maintenance of regulatory database and project status of on-going and planned submission. Tracking regulatory guidelines, regulatory forums and agency website on regulatory intervals. Impart regulatory related training across the department.