Regulatory Pharmacist
Full-time
Progressive Medical Corporation
KEY RESPONSIBILITIES:
Product Registration
- Prepares all documents necessary for product registration such as technical data, physical description or specification, list of raw materials and manufacturing process, certificate of free sale, GMP / ISO certificate and other pertinent documents as required by BFAD / government agency.
- Submits requirements and facilitates approval of new product registration.
- Coordinates with principal/suppliers on documents needed to facilitate registration.
- Monitors expiration of all CPR and facilitates renewal and authentication.
- Liaises with regulatory agencies regarding product registration or exemption.
- Monitors successful and complete product registration.
Record / Reports
- Files properly and accurately all product and company documents and makes necessary control, release, and borrowing of original copies and photocopies.
- Prepares registration status report (Patent / BFAD / DOH) to Sales & Marketing Head.
- Prepares Product Registration summary quarterly.
- Prepares Suppliers Update annually.
Others
- Assists on bidding by preparing all documents required by the accounts.
- Assists on sample requisition and releasing in the absence of ProductSpecialist.
- Maintains level of confidentiality.
- Performs other duties that maybe assigned from time to time.
Authority
- Authorized to liaise with regulatory agencies for product registration/exemption; coordinates with principals/suppliers and control all product documents.
Vacancy posted 26 days ago
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