Regulatory Officer
Regulatory Officer
Octarine2-4 Years
- Posted 10 hours ago
- Be among the first 10 applicants
Job Description
Responsibilities
- 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.
- 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.
More Info
Key Skills
cosmetic raw materials
Halal Assurance System
MESKOS Reports
5R workplace organization principles
CPKB Good Manufacturing Practices for Cosmetics
BPOM notification
cosmetic regulations
Production Reports
DIP documentation
About Company