Assistant Manager

3 weeks ago


India Biocon Full time

Department Details Role Summary We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Regulatory Publishing team In this role you will be responsible for preparing and submitting high-quality electronic submissions eCTD NeeS to global health authorities ensuring compliance with international regulatory standards Key Responsibilities RESPONSIBILITIES Strong understanding of eCTD NeeS and ICH guidelines Familiarity with Regulatory systems and Publishing tools Use publishing tools such as Lorenz Docubridge Ectd Validator ISI Toolbox Adobe Acrobat MS Excel SharePoint Ability to perform end-to-end eCTD submission process including Document level Publishing and Dossier compilation and dispatch of submissions to respective Health Authorities Developed and ROW Markets o Manage lifecycle submissions including variations amendments and renewals o Perform document-level publishing hyperlinking bookmarking and validation o Conduct quality control checks to ensure submission readiness o Collaborate with cross-functional teams including Regulatory Affairs CMC and Clinical o Stay updated with global regulatory guidelines ICH FDA EMA o Detail-oriented with a collaborative mindset Educational Qualifications Required Education Qualification B Sc Required Experience 5 - 10 years


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