Lowongan REGISTRATION MANAGER di PT Etana Biotechnologies Indonesia

Job Description:

• Communicating with the plant team and the principal for a list of documents needed to apply for a license (drug registration or other licensing)​
• Evaluating product registration documents (local and import) received from the plant team and principal, and making they comply with the applied registration category.​
• Prepare the product registration to BPOM, 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 & principal, which has been requested by related government agencies or by self-assessment, e.g new product registration, variation, renewal for all the registration categories (NCE, Biological Products, Generic Drug, Biosimilars.)​
• Ensure timely approvals of new product registration, variations, and renewals.​
• 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 coordinate 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, and create strategies which in line with the company's goal.​
• Develop and maintain a good and professional relationship with appropriate government agencies to ensure a smooth and efficient registration process.​
• Prepare documents for Trade Mark registration to the Directorate General of Intellectual Property.​
• Prepare documents for Patent registration to the Directorate General of Intellectual Property.​
• Follow up on the status of each license that has been submitted to the government (NADFC, Ministry of Health, Directorate General of Intellectual Property).​

Requirements:

• Must have Bachelors Degree in Pharmacy â€‹
• Must have 10 years of experience in a related field â€‹
• Excellent skills in communicating with the team, evaluating and preparing the product registration documents for BPOM â€‹
• Strong understanding of government regulation â€‹
• Good Relationship and extensive networking with BPOM, MUI, MoH, etc. â€‹
• Fluent in English (both written and verbal) â€‹
• Have a high sense of integrity and strong leadership â€‹
• Willing to work overtime if needed â€‹
• Willing to work independently (self-motivated) and within a complex team environment â€‹
• Willing to be stationed in East-Jakarta â€‹