Officer / Sr. Officer - Regulatory Affairs EU/UK

Unichem Laboratories

2 - 4 years

2 - 6 Lacs

Mumbai

Posted:3 hours ago| Platform:

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Skills Required

Ectd MAA submission CTD

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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