As Regulatory Manager, line massages 2 Pharmacist (Spv and staff) and 1 administration staff a. Manage and Pursuing with maximum efficiency for Registration approval of : - Drugs (New Drug, Generic, Brand Generic) local, import and export products at NADFC (Badan POM) - Health Supplement and, Traditional Medicine, both for Local, Export and Import Products at NADFC (Badan POM) - Medical Device, certification service At Ministry Of Health, - Medical Device Distributor License ( or known in ID as SDAK) - Certificate of of Good Medical Device Distribution (or known as CDAKB) - Press And Electronic Advertising - Halal Certification Products - Intellectual Property, trademark certificate at Ditjen HAKI - On Line Single Submission System (Integrated System)b. Manage dossier with CTD format for export productc. Developing and Improving Regulatory system for continuity activityd. Manage Pharmacovigilance system and routine activitye. Manage commercial license at BPOM and MOH f. Developing, implementing and maintaining Regulatory Affairs systems and activities within The National Agency of Drug and Food Control (NADFC), Ministry Of Health (MoH) and others guidelines and facilitate relations with key regulatory authorities and decision-makers g. Provide registration strategic and management for new product launches, also for tender products to be aligned with current guidelines from local and foreign Authorities h. Ensure that all regulatory Dossiers are maintained and updated to be aligned with current guidelines from local Health Authorities (NADFC, MoH) and International Guideline, if adapted i. Plan and control regulatory expenditure, ensuring cost efficiency at all times and particular focus on controllable expenses. j. Actively participate in the development of the company’s business and active role in the organization of regulatory Affairs

As Regulatory Manager, line massages 2 Pharmacist as Senior and Regulatory officer and 1 administration staff - Manage with maximum efficiency for Registration approval product of :- Health Supplement, Traditional Medicine, QUASI & Cosmetic Notification both for Local and Import Products - Food at BPOM- Medical Device At Ministry Of Health- Press And Electronic Advertising- Halal Certification Products For Health Supplements And Food Products both for local and Impor-- MEREK certificate at Ditjen HAKI-Food L icense, Cosmetic Production License, IOT and CPOTB LicenseDeveloping, implementing and maintaining Regulatory Affairs systems and activities within The National Agency of Drug and Food Control (NADFC) and Ministry Of Health (MoH) guidelines and facilitate relations with key regulatory authorities and decision-makers Provide registration strategic and management for new product launches of all products (Food Suplements, Traditional medicines, Cosmetics, Foods and Medical Devices to be aligned with current guidelines from local Health Authorities (NADFC, MoH) and International Guideline, if adapted. Ensure that all regulatory Dossiers are maintained and updated to be aligned with current guidelines from local Health Authorities (NADFC, MoH) and International Guideline, if adapted Optimize cross-functional support needs in the organization, ensuring effective communication between direct reports and with the R&D, Supply Chain, Legal, Marketing and principle. Plan and control regulatory expenditure, ensuring cost efficiency at all times and particular focus on controllable expenses. Actively participate in the development of the company’s business and active role in the organization of regulatory Affairs