Regulatory Officer

Tanggung jawab

• Manage product notification registration with BPOM.
• Prepare and maintain the Product Information File (PIF/DIP) documentation.
• Monitor the completeness, accuracy, and updates of PIF/DIP and BPOM notification documentation.
• Prepare and submit Production Reports and MESKOS Reports to BPOM on a semi-annual basis.
• Prepare and report alcohol usage documentation in compliance with applicable regulations.
• Prepare Material Safety Data Sheets (MSDS) to support product distribution requirements.
• Prepare Certificates of Analysis (CoA) as supporting documentation, including for air freight shipments.

Persyaratan

• Bachelor's degree in Pharmacy or a licensed Pharmacist (Apoteker).
• Minimum 2 years of experience in a similar role.
• Certified in Product Information File (PIF/DIP) and Cosmetic Safety Assessment, with the ability to perform Margin of Safety (MoS) calculations.
• Strong understanding of cosmetic regulations and cosmetic raw materials.
• Good knowledge of CPKB (Good Manufacturing Practices for Cosmetics), Halal Assurance System, ISO standards, and 5R workplace organization principles.