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    Senior Executive - Mumbai, India - Encube Ethicals Private Limited

    Encube Ethicals Private Limited
    Encube Ethicals Private Limited Mumbai, India

    Found in: Talent IN 2A C2 - 1 week ago

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    Description

    Job description

    Education

    PG: MS/M.Sc (Science) in Any Specialization, M. Pharma in Any Specialization

    Required Experience :- 3 to 8 years (Experience in US market preferred)

    Role & responsibilities

    • Experience in US submissions.
    • Dossier review and compilation of ANDAs for the US market.
    • Post approval for US market.
    • Document review i.e. specifications, batch records, method validation documents, stability data, container closure system, DMF review.
    • Hands on Electronic operation (eCTD & SPL).
    • Labelling related activities.

    Preferred candidate profile

    • Team Handling Experience is preferred.
    • Experience in US submissions.
    • Knowledge of CMC Documentation required for Submissions.
    • Knowledge & Experience of Pharma ready Software.

    Role: Legal & Regulatory - Other

    Industry Type: Pharmaceutical & Life Sciences

    Department: Legal & Regulatory

    Employment Type: Full Time, Permanent

    Role Category: Legal & Regulatory - Other

    Interested candidate can share their updated resume on


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