Regulatory Pharmacist
1 week ago
FUNCTIONS:
- Maintenance of Product Registration
- Review and preparation of Registration Dossier and Variation applications
- Review of Distribution Records
- Maintenance of PV Reports
- Submission of Batch Notification
- Coordinate with toll manufacturer on Regulatory matters
- Coordinate closely with R & D Team
- Preparation of response to queries and concerns from Regulatory Authorities within the specified timeframe
- Liaise with RA counterpart of respective Principals
- Provide support to Sales and Marketing in matters relating to regulatory issues affecting sales and promotion
QUALIFICATIONS:
- Licensed Pharmacist
- With experience / knowledge in:
- Maintenance of Product Registration & FDA – issued License to operate
- Compliance to PIC/s GMP Requirements
- Pharmacovigilance
- Preparation of facsimile labels for product registration purposes
- Possesses good communication and leadership skills
- Aggressive, analytical, hardworking and result oriented
- Computer literate
We give our employees compensation packages:
- Basic salary plus merit & meal and transportation allowances
- 13th, 14th and 15th month bonuses
- Career development and professional growth
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