Alembic Pharmaceuticals logo

Sr. Executive/Assist. Manager/Dy. Manager - Regulatory Affairs

7 - 15 years

7 - 15 Lacs

vadodara gujarat india

Posted:1 month ago| Platform: Foundit logo

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Skills Required

drug regulatory affairs regulatory affairs ctd dossier preparation dossier compilation

Work Mode

On-site

Job Type

Full Time

Job Description

Job Criteria:

  • B.Pharm or M.Pharm qualification having experience between 7 - 15 yrs. with dossier filling experience in

    MEXICO or South East Asian

    Countries.
  • Knowledge for review of quality documents like executed batch documents, method validation, change
  • Good communication skill

Job Responsibility:

  • Compilation and review of product license applications, variations, and renewals for Mexico country as per regulatory requirements respectively with minimal supervision
  • Manages electronic documents and creates electronic submissions in CTD format.
  • Preparation and review of responses to authority questions during registration and product lifecycle.
  • Keep track of assigned projects and follow-ups to ensure the Dossier is delivered as per set timeline/commitments.
  • Designing, Reviewing & Approval of Artwork required for registration purposes. Dossier due diligence for products being in-licensed from other company
  • Support in preparing the meeting materials as needed, eg, regulatory project status/ submission/ approval information monthly, quarterly or yearly.

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Alembic Pharmaceuticals logo
Alembic Pharmaceuticals

Pharmaceuticals

Vadodara

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