Job Title

Experience- 5 to 7 YrsRESPONSIBILITIESCompilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ. Publishing in eCTD format and submission to respective Regulatory Agencies.Compilation and submission of variation applications for EU, UK and AUS-NZ.Review of documents related to compilation of dossiers and query responses.Up to date knowledge of regulatory guidelines and requirements.DESIRED SKILLSMust have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycleShould have handled initial MAA submission & Variations for EU.Good technical knowledge, review skills and understanding of regulatory submissionsStrong knowledge of CTD /eCTD requirements for modules 2 and 3 is mandatory.Hands on experience with compilation of module 1 and portal submissions would be preferable.Ability to try new approaches when faced with challenges.Should have good analytical and learning attitude.Good communication (written and oral) and inter-personal skills.