Regulatory Affairs- Executive

2 weeks ago

Mumbai, Maharashtra, India Unichem Laboratories Limited Full time
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.

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