Executive - Regulatory Affairs (API)

As a Regulatory Affairs Specialist, you will be responsible for the following tasks: Preparation of CTD/eCTD format drug master file and its submission to various regulatory authorities including USA, Europe, Canada, Australia, China, Japan, Korea, Brazil, and ROW market. This includes ensuring compliance with the specific requirements of each regulatory body. Handling the preparation of query responses for drug substances in both highly regulated and less regulated markets, catering to the needs of diverse customers. Creating applicant parts and closed parts for submission to different regulatory authorities on behalf of various clients. Managing the annual updates and amendments of drug master files for the US through ESG, ASMF via CESP, and KDMF via MFDS Korea to maintain regulatory compliance. Coordinating the preparation and submission of CEP (Certificate of Suitability of Monographs of the European Pharmacopoeia) applications and responses to the European Directorate for the Quality of Medicines (EDQM) via CESP. Preparing CEP Letters of Access (LOAs) and declarations for customers and regulatory authorities as required. Conducting research to collect and evaluate scientific data for regulatory assessments and compiling the necessary documentation for submissions to authorities and clients.,