Officer / Sr. Officer - Regulatory Affairs EU/UK

1 week ago


Mumbai, Maharashtra, India Unichem Laboratories Full time US$ 80,000 - US$ 1,20,000 per year

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.


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