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.
Robust 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 recent approaches when faced with challenges.
Should have valuable analytical and learning attitude.
Good communication (written and oral) and inter-personal skills.