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    Officer / Senior Officer- Regulatory Affairs - EU - Mumbai, India - Unichem Laboratories Limited

    Unichem Laboratories Limited
    Unichem Laboratories Limited Mumbai, India

    1 day ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Position Overview:

    • Handling assigned activities in the regulatory department.

    Experience:

    • 5-8 years

    Qualification:

    • B. Pharm, M.Pharm preferred.

    Responsibilities:

    • Compilation of ANDA submissions in accordance with the latest guidances assuring technical congruency and regulatory compliance.
    • Identify the required documentation for EU regulatory submissions and compilation of MAA submissions for EU accordance with project timelines.
    • Review and identify content, and documents, related to dossiers compilation or query response.
    • Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
    • Providing responses to queries and issues received from regulatory authorities proactively.
    • Compilation and submission of CBE-0, CBE -30, labelling supplements and annual reports and variation applications for EU.
    • Generation and submission of SPL for drug listing.

    Desired Skills:

    • Must have hands on experience on using eCTD software and attending e-publishing requirements throughout project lifecycle.
    • Should have handled original MAA submission for EU.
    • Good technical knowledge, review skills and understanding of regulatory submissions.
    • Strong knowledge of CTD /eCTD requirements for submission of dossiers.
    • 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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