Regulatory Affairs- Executive / Sr Executive - EU / UK

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 eCTD 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 eCTD 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 / eCTD 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.