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    Regulatory Affairs Executive - Mumbai, India - Encube Ethicals

    Encube Ethicals
    Encube Ethicals Mumbai, India

    6 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Key Deliverables

    Dossier review and complication of ANDAs for US Market.

    Post approval for US

    Document review i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.

    Hands on Electronic Operation (eCTD and SPL)

    Labelling related activities

    Skills and Requirements

    Experience in US submission

    Experience in US submission

    Knowledge of the review of CMC documentation required for submission

    Working capabilities preferably on PharmaReady software

    Understanding labelling related guidance's

    Positive Attitude and Approach. Learning Abilities



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