Officer / Sr. Officer - Regulatory Affairs EU/UK

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 with respect to solid oral dosage forms.
• Adept at review of manufacturing and analytical documentation from a regulatory perspective.
• Strong knowledge of CTD /eCTD requirements and hands-on experience with compilation of CTD modules 1 to 5 is mandatory.
• Hands on experience with 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.