Regulatory Pharmacist

2 days ago

Pasig, National Capital Region, Philippines Medical Center Trading Corporation Full time ₱1,200,000 - ₱2,400,000 per year

JOB LOCATION: KAPITOLYO PASIG CITY

JOB REQURIEMENT: LICENSED PHARMACIST

DUTIES AND RESPONSIBILITIES:

1.0 Application,Process and Compliance

A. FDA Regulatory Requirements

1.1 To update timely Certificate Medical Device Notification (CMDN), Certificate of Medical Device Registration (CMDR), License to Operate (LTO) and sales promo permit.

1.2 To request and prepare the following documentary requirements to the suppliers intended for application of CMDN, CMDR and Sales Promo Permit subject for Regulatory manager's approval.

1.2.1 Suppliers Legal and Technical documents

1.2.2 Artwork in compliance to FDA Labeling guidelines

1.3 To request and prepare the following documentary requirements to the suppliers intended for application of LTO subject for Regulatory manager's approval.

B. BOC Shipment's releasing supporting documents

1.4 To prepare and update FDA Licenses and Certificates, external ISO Certificates and other technical documents as needed.

C. MCTC Stores FDA Requirements

1.5 Provide assistance in compliance with deficiencies related to the Standard Operating Procedures

1.6 Provide updated documents such as LTO, Calibration certificate and FDA Licenses and certificates

2.0 Coordination to the FDA, DOH and other Government Agencies

2.1 Act as alternative liase with FDA for status of submission, payment and release of certificate, as needed.

2.2 Act as alternative liases with FDA-lab and DOH-MMD for schedule of product sampling as a requirement to the government bidding, as needed.

2.3 Act as alternative liases with BOC for the documents needed in support to the shipment documents, as needed.

2.4 Act as alternative representative in FDA-CDRRHR and other Government Agencies, when assigned by the superior.

3.0 Handling of Documents

3.1 Maintaining the Hardcopy of the CMDN, CMDR, LTO, FDA issued certifications and other Government- issued certificates

3.2 Ensuring that the certificate and licenses are valid and accurate

3.3 Monitor the validities of supplier's issued Legal documents, Government issued certificate and licences.

4.0 Other Duties and Responsibilities

4.1 Act as alternative in thorough review of following documents prior to approval for timely submission:

4.1.1 Documentary requirements for application

4.1.2 Artwork Approval, Purchase Requisition slip and Purchase order from suppliers for approval.

4.2 Assist superior in conducting FDA presentation updates to the management, sales and marketing dept., local and foreign suppliers and forwarders as needed.

4.3 Attend seminar/conventions/trainings

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