BriefCase
BriefCase

Officer/ Executive - Qa (regulatory) Job in Leben Life Sciences

Officer/ Executive - Qa (regulatory)

Leben Life Sciences 4+ weeks ago
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Job Summary

Minimum experience required in this position:

3+ years

Description:

Roles & Responsibilities :-

  • Preparing, registration and compiling of the country specific Dossiers for various Products.
  • Compiling and submitting the tender document to African Market.
  • Preparing of dossier in CTD format as per ICH Guidelines.
  • Solving the queries related to the dossiers in timely manner.
  • Preparing and maintaining registration and document status.
  • Reviewing analytical method validating, process validation and other analytical data of plant.
  • Having Knowledge of FDA related work and documents.
  • Handing ERP system.
  • Handling literature search activities required for preparation of dossiers (mainly pre-clinical, clinical & medical prescribing information.)
  • Handling queries of customers / Health Authorities and tender documents.
  • Developing regulatory strategy and implementation plans for preparation & submission of new products.
  • Monitoring impact of changing regulations on submission strategies and update internal and external stakeholders for regulatory filing related documentation
  • Co-ordinating the activities for the arrangement of sample along with COA & MSDS- sample for registration and tender.
  • Giving inputs for any query raised by other departments required for regulatory submission.
  • Performing any other work assigned by HOD.

    • Highest Qualification :-

    B. Pharmacy / M. Pharmacy

    Location :-

    Akola
    Experience Required :

    Minimum 3 Years

    Vacancy :

    2 - 4 Hires

    Apply Now
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