Role & responsibilities
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 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 addition of Recent Products in WHO GMP List
Checking of Artwork, Leaflets of both International and Domestic Supplies
Participate in writing and update SOP/Work Instructions and process improvements
Travel to Manufacturing Units during the Audit by External Agencies
Preferred candidate profile
Takes full responsibility of getting the documents organised and filing the product for registration at various countries Ministry of Health
Willing to travel to manufacturing unit during International Audits for 5 to 7 days on comany account.