Gastroenterology
Global

Gastroenterology Experts

Remi Chalhoub

Senior RA Officer
Regulatory
Benta Pharma Industries Lebanon
Lebanon

Biography

Senior Regulatory Affairs officer at Benta Pharma Industries- BPI July 2011 - Present - Review all DMFs/CTDs received from suppliers for Biotech Products and coordinates requests for clarifications/missing documents accordingly. - Update CTD files versions of Biotech Products upon any change. - Review registration and tenders requirements in all export countries for Biotech Products and prepares Registration Files. - Follow up on all technical requests for Biotech Products initiated from RA and other business units with Supplier. - Acknowledge receipt of all files and samples already requested from suppliers for Biotech Products. - Prepare registration files, variations, and notifications to MOH for all biotech products to the Lebanese MOH. - Prepare reply to MOH queries for all Biotech files prepared and submitted for Lebanon and Export Countries. - Ensure the appropriate filing (soft and hard copies) for all biotech documents related to export files. - Write all procedures related to local registration of Biotech Products in RA department. - Handling the preparation of all Registration Files, variations, and notifications for Wadi ElNeel Benta, in accordance with Egyptian Guidelines and Requirements. - Prepare reply to Egyptian MOH queries for all Wadi ElNeel Benta files prepared and submitted. - Review on all documents prepared in Egypt and coordinates requests for corrections, clarifications, and missing info accordingly. - Review cartons, labels, and inserts mock-ups for all products related to Wadi Elneel Benta-Egypt. - Ensure the appropriate filing (soft and hard copies) for all Egypt documents. - Update all follow up sheets related to status, submission and approval of registration files in Egypt, and all biotech products in export countries. Education Université Jean Monnet Saint-Etienne Executive masters in business administration eMBA, 2014 - 2016 Lebanese University  

Research Interest

 Regulatory

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