Regulatory Supervisor

Kewajiban

• Communicating with the plant team and the principle for a list of documents needed to apply for a license (drug registration for local and imported or other licensing) based on the regulation
• Evaluating product registration documents (local and import) that received from the plant team and principle, and make it comply to the applied registration category
• Prepare the product registration to BPOM for new product, variation, and renewal of products, and ensure the documents are in accordance with product registration requirements so the additional data which is requested by BPOM could be minimized
• Coordinate the lacking of registration documents to the plant team & principle, which has been requested by related government agencies or by self-assessment, e.g new product registration, variation, renewal for all the registration category (NCE, Biological Products, Generic Drug, Biosimilars)
• Follow-up on the status for each product registration & license which has been submitted to the government (NADFC, Investment Coordinating Board of the Republic of Indonesia, Ministry of Health)
• Ensure timely approvals of new products registration, variations and renewals
• Review product labeling documents (box, blister/strip/sticker, insert) prepared by RnD team as required
• Prepare and evaluate documents for licensing document, such as Pharmaceutical Business Licence (Ministry of Health), as well as other licensing documents to related government agencies, and coordinate with the plant team if there are deficiencies or questions requested by related government agencies
• Support the preparation of submission and / or renewal of the GMP Certificate to NADFC, as well as coordinating with the plant team if there are deficiencies or questions requested by NADFC
• Provide the update regulation periodically related to the Pharmaceutical Industry in Indonesia from various government divisions, such as BPOM, Ministry of Health, etc
• Follow the inspection process from various government divisions, and ensure the documents for inspection needs are in accordance with regulations
• Develop and manage product registration, create strategies which in line with company's goal
• Develop and maintain good and professional relationship with appropriate government agencies to ensure smooth and efficient registration process