Senior Manager

Job Description

Major purpose of the Job : Review of eCTD dossiers/renewal applications/variations/any other post marketing applications for ICH regions- EU, UK. Knowledge about Canada and ANZ is beneficial but not Mandatory. 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 (R&D, Manufacturing, QA, QC & International marketing (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 documents like 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. Role & responsibilities Preferred candidate profile Support the International SBU through various activities like preparation of Registration dossiers, Renewal of dossiers, Submission of Variations, Query response, Initiation of Change Controls, Creation & Maintenance of Regulatory Database and any other assignments as specified by the reporting authority for Europe, Canada, United kingdom (Region III, IV) countries.