Department
Regulatory Management and R & D – AL
Job Description
- Prepare product registration / renewal dossiers according to the regulatory requirements of MOH - Overseas using ACTD / ICH – CTD and / or relevant regulatory guidelines.
- Prepare product variation applications using ACTD / ICH – CTD and / or relevant regulatory guidelines.
- Prepare query compliance documents for submission to MOH – Overseas.
- Coordinate with QA & Compliance / QC / R&D / Validation for any inquiry on Manufacturing Process and Testing Method.
- Prepare monthly plan, minutes of meeting and progress trend analysis.
- Prepare initial text of insert and composition of artworks for registration & commercialization purpose.
- Assist in preparation of change alerts for any change in regulatory management system.
Education
Pharm-D from an accredited University
Experience
1 to 2 Years of Pharmaceutical Regulatory experience
Skills
- Must have knowledge of basic regulatory requirements
- Must have good analytical / review skill
- Must have knowledge of quality documents such as BMR, FPS. Certificate of analysis and Validation etc
- Must be proficient in Microsoft Word