Dr. Raymond Onechanh

Input into all stages of company’s portfolio products and develop strategies, Manage preparation of Regulatory Documentation and coordinate Regulatory Procedure (i.e. MAA through centralised procedure including eCTD dossier preparation of module 1 to 5, Orphan Drug Designation, Pediatric Investigation Plan, SME renewal, Clinical Trial Application including preparation of IB and IMPD ....), Coordinate Agency meetings

EU Marketing Authorization procedures, Prepare and provide constructive review of regulatory dossiers (MAA, CTA, etc.), Clinical summaries (investigator’s brochure, synopsis, study protocol, clinical study report) and Pharmacovigilance report (PSUR, Benefit-Risk assessment), CMC variations (type I & II), Write product information and CCSI variation files (type II), Coordinate meetings with Regulatory agencies, Regulatory strategy, Regulatory intelligence, Write Standard Operating Procedures

Pharmaceutical regulation, Healtcare law

Pharmacy, Course in Bio-Therapies (Biotechnology, Gene Therapy, Cellular Therapy), Certificate in Mechanism of Action of Toxicological Products: Biochemical Toxicology, Certificate in Physico-Chemical Methodology of Analysis