Paranaque City Jobs Regulatory Affairs Supervisor Position at Zuellig Pharma Corporation

Job Info

Company	Zuellig Pharma Corporation
Position	Regulatory Affairs Supervisor
Region	Paranaque City
Career Level	Supervisor/5 Years & Up Experienced Employee
Work Experience	5 years
Qualification	Bachelor's/College Degree, Professional License (Passed Board/Bar/Professional License Exam)
Type of Work	Full-Time
Minimum Salary	PHP 16.000
Maximum Salary	PHP 38.000

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 maintenance
• Responsible for the review of NPIS vs. CPRs and providing product classification
• Monitoring 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 Sucat, Muntinlupa

KNOWLEDGE AND SKILLS REQUIREMENT

• Must have adept knowledge of the company’s operations.
• Must have basic understanding of ISO 9001:2015
• Must 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)

Apply for Work

Company Description

Company Info

• Industry: Healthcare / Medical
• Company Size: 1001 - 2000 Employees
• Average Processing Time: 25 days
• Benefits & Others: Dental, Medical, Loans, Regular hours, Mondays - Fridays, Business (e.g. Shirts), Performance Bonus