Regulatory Affairs Specialist

Kewajiban

• Actively involved in new product registration and launching, review registration dossier, monitor & performing best approach to registration process, and to provide update to cross-functional team in new product launch plan in order to ensure alignment to company strategy. • Prepare and compile registration dossier for New Drug Application based on company data file or standard in accordance to Indonesia local HA (BPOM) requirement including other components of the registration package and ensure that the dossier is of high quality and accuracy completed in a timely and efficient manner also keep follow up and monitor progress of registration filing to achieve approval within target timeframe. • Maintain registration number by on time renewal registration submission by preparing registration dossier in accordance to FDA requirement and follow up registration process to achieve approval within target timeframe. • Follow up all registration changes which come from global and local by preparing dossier registration and on time submission and approval within target timeframe for Labeling Update (Safety and Non-safety) and CMC. • Finding information and analyze about regulatory requirement and updating any new regulation also giving guidance/recommendation/direction based on gathered regulatory information to related parties. • Ensure to be cognizant of, and compliant with, all relevant Indonesian regulatory legislation and guidelines as issued by the Indonesian governments, BPOM, Company Corporate Procedures and Local Country Standard Operating Procedures (SOPs). • Ensure that all regulatory database is 100% updated by providing updating information on time to regional/global. • Ensure and do verification packaging to comply with the regulation, registered and approved specification. • Conduct regulatory Intelligence by fully aware with what our competitor by finding out important information from other companies through corridor conversation and also through other media (internet, etc.). • Support CFT team for post launching activities by providing required document. • To complete special task/Subject Master Expert that is assigned by Supervisors and Management.