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Regulatory Affairs- Executive / Sr Executive - EU / UK
Unichem Laboratories Limitedmumbai, maharashtra, in24 days ago
Job descriptionMust 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.
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
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Sr Executive • mumbai, maharashtra, in
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