Regulatory affairs- executive

4 weeks ago


Mumbai, India Unichem Laboratories Limited Full time

Experience- 5 to 7 Yrs RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ. Publishing in e CTD 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 SKILLS Must have hands on experience on using e CTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge, review skills and understanding of regulatory submissions Strong knowledge of CTD /e CTD 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.



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