Full Time Regulatory Affairs Specialist Jobs, in Genedrift - Maukerja

• Ensuring necessary compliance with FDA, local laws/authoritiesEvaluating dossiers for submissions, submission of dossiers both offline/online, and following up for status of dossiers/queries with FDA.Responding to necessary queries, and meeting staff at FDA for the resolution of queries. Represent clients for all matters relating to registrations and audits, and communicate with customers within Malaysia for resolving queries / FDA issues. Ensure the upkeep and safe custody of all original documents and recordsStay updated and continuously update internal documentation with reference to the guidelines of FDAMeet with clients and pitch them the services of the company for Malaysia and other markets.

Have knowledge and experience in applying for registrations, variation, and related activities with FDA.

• Have experience in submission of dossiers for Drugs, Cosmetics, etc with the FDA.