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Unichem Laboratories logo
Officer / Sr. Officer - Regulatory Affairs EU/UK Unichem Laboratories

2.0 - 4.0 years

2 - 6 Lacs

Mumbai

Work from Office

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU and/or UK. Review of documents related to compilation of dossiers, variations and query responses. Up to date knowledge of EU regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge w...

Posted 3 months ago

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