Ass.Manager - RA (Formulation)
1 month ago
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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