Ass.Manager - RA (Formulation)

1 month ago

mumbai, India BEST-FIT Recruitment Riders Full time

Job Profile:

  • Responsible for collection & preparation of plant-level documents for regulatory submission.Product Registration as per registration guidelines of different countries and regulatory submission.
  • Prepare and submit variations to authorities. Follow up on submissions, timelines, and approvals, with the concerned person.
  • Well versed with CTD formats and dossier preparation.
  • Ensuring samples are sent timely and coordinating with a concerned person for submission, getting the receipts, and follow-up on the registrations.
  • Checking COAs before dispatch of Commercial Orders.
  • Application of Product Permissions, COPPs, and coordination for the addition of New Products in WHO GMP List.
  • Checking of Artwork, Leaflets of both International and Domestic Supplies.
  • Participate in writing and updating SOP / Work Instructions and process improvements.
  • Travel to Manufacturing Units during the Audit by External Agencies.


Desired Profile:

  • B. Pharm / M. Pharm with 4.0 to 7.0 yrs of experience in Regulatory Affairs in Formulation with growing Pharma in Semi Regulated / ROW markets.
  • Should have good understanding of Regulatory Affairs life cycle for Solid Oral, Parenteral & Topical Formulations.
  • Candidate must have very good writing & communication in English.

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