Regulatory Affairs Supervisor (Cebu)

DUTIES AND RESPONSIBILITIES:

Regulatory Affairs Related

A.  Food and Drug Administration (FDA)

1.Product Registration

Assists the RA Manager in the application process for product registration

2.Certificate of Product Registration

Responsible for monitoring and updating of principal’s CPR; file and system maintenanceResponsible for the review of NPIS vs. CPRs and providing product classificationMonitoring reports containing records of products with Batch Notification and Lot Release Certificate

3.License to Operate Applications

Assist the RA Manager in dealing with the FDA’s various activities such as License to Operate, initial/renewal/validation applications as Drug, Medical Devices, Cosmetics and Food Distributor/Repacker, product registration of all imported goods of suppliers. Requests for additional source/principal or deletion of the source/principal.Responsible in providing the regulatory agency with all the pertinent requirements necessary for the issuance of various licenses.Responsible for the authentication of LTO by the FDA as required by the Department of Health during bidding of drugs, medical devices, collection purposes, etc.Maintains authenticated LTO copies on file for various purposes.

4.Various Reports/documentation

Responsible in the submission of written reports such as destruction reports, other reports that any government agency may require.Ensures availability of reference books and record books duly registered with FDA.Responsible in the procurement of test analysis of various supplies for bidding, collection purposes, etc.Responsible for follow-ups of various documents such as test analysis, product registration status, certification clearances, etc.

5.As Pharmacovigilance Officer, responsible to carry out the pharmacovigilance SOP of MDI.

6.Other responsibilities that may be given from time to time.

B.  Philippine Drug Enforcement Agency

1.Liaison Officer

Authorized representative of the company empowered to deal with Philippine Drug Enforcement Agency (PDEA) with regards to drugs that are classified as dangerous drugs.Facilitates renewal of license to handle PDEA Controlled substances and other related reports.

2.Submission of a computerized report

Responsible for submission of a computerized report of all dangerous drugs’ receipts, issuances on or before cut off dates established by the bureau.

3.Damaged Stocks

Responsible for providing FDA a report on damaged dangerous stocks and submits the actual stocks to their office for scheduled destruction.

4.Updates

Responsible in keeping MDI abreast of any updates.

5.Other responsibilities that may be given from time to time.

Responsibilities Related to Operations

1.S License Monitoring

Monitoring of customer’s S license ensuring that all procurers of regulated drug products are duly licensed / authorized. Also, to ensure that all S licenses are updated and not expired.

2.Conduct regular cycle count of regulated and dangerous drugs to ensure 100% accuracy of actual stocks vs. system balance.

3.Review of NPIS vis-à-vis principal CPRs and providing the correct product classification

4.Review of CARF in relation to validating customer LTO

System Management

May be assigned in systems management projects which will require working with a team on review of processes, data collection and analysis and identification of risks. Depending on the assigned project, the work will involve:

1) making recommendations to improve controls and ensure compliance to company policies and relevant standards and/or

2) developing policies, standards and procedures for operations and systems in MDI.

Performs other duties that may be given from time to time by the immediate superior.

EDUCATION REQUIRED

Registered Pharmacist.

EXPERIENCE REQUIRED

Minimum of three years exposure of the same capacity

LOCATION

Amenable to work in Mandaue City, Cebu (Dr. F.E. Zuellig Ave. North Reclamation Area, Mandaue City, Cebu)

KNOWLEDGE AND SKILLS REQUIREMENT

Must have adept knowledge of the company’s operations.Must have basic understanding of ISO 9001:2015Must have good working knowledge of MS Office (especially on Word, Excel and Powerpoint)Must have good oral and written communications skills.Must have initiative and good judgment.Must have good planning and organizational skills.Must be approachable and flexible.Must be proactive and good leader.Must be organized and systematic in handling schedules and workflows.An ability to find out independently how to find out (resourcefulness)