Gabriella Pasaribu
Regulatory Affairs Assistant Manager @PT Kalbe Farma, Tbk
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WORK HISTORY
Regulatory Affairs Assistant Manager @PT Kalbe Farma, Tbk
Jakarta, ID
As Regulatory Affairs in PT Global Onkolab Farma (A Kalbe Company):\\\\n1. Review and build new product, renewal and variation dossier (Local and Export) for Oncology Drug to be evaluated by BPOM (Indonesia National Agency of Drug and Food Control).\\\\n2. Follow up registration process to obtain marketing authorization in timely manner.\\\\n3. Monitor, follow up and submit CAPA to regulatory authority to obtain manufacture certification.\\\\n4. Monitor and anticipate current and new health regulations.\\\\n5. Ensure various project i.e. increase product\'s TKDN value and support cost saving.\\\\n\\\\nAs Corporate Regulatory Affairs:\\\\n1. Monitor dan report regulatory compliance in Kalbe Group.\\\\n2. Build regulatory manual and conduct gap assessment to sister companies in Kalbe Group.\\\\n3. Prepare schedule, conduct and coordinate internal audit.\\\\n4. Identify training need for regulatory and organize the training.\\\\n5. Monitor and anticipate current and new health regulations.\\\\n6. Assist and monitor regulatory projects, i.e. support regulatory IT system based on regulatory standard\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
EDUCATION
University of Indonesia
Bachelor of Pharmacy (B.Pharm.), Industrial and Physical Pharmacy and Cosmetic Sciences
ABOUT GABRIELLA PASARIBU
Experienced Regulatory Affairs Specialist with a demonstrated history of working in the pharmaceuticals industry. Skilled in Mathematics, Adobe Photoshop, Video Editing, and Microsoft Office. Strong legal professional with a Bachelor of Pharmacy (S.Farm.) and Apothecary Professional (Apt.) degree focused in Industrial and Physical Pharmacy and Cosmetic Sciences from University of Indonesia.
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