Department
Regulatory Management and R & D – AL
Job Description
- Collate and compile technical documents for preparation of product registration / renewal dossiers according to the regulatory requirements of MOH - Overseas.
- Collate and compile technical documents for preparation of product variation applications according to the regulatory requirements of MOH - Overseas.
- Assist in preparation of query compliance documents for submission to MOH – Overseas.
- Assist in preparation of monthly plan, minutes of meeting and progress trend analysis.
- Ensure the maintenance of record and log books for correspondence, accomplishments, queries and technical documents.
Education
Pharm-D from an accredited University
Experience
6 months experience in a Pharmaceutical Company
Skills
- Must have knowledge of basic regulatory requirements
- Must be proficient in Microsoft Word