Regulatory Affairs Officer - Pharmacy

ORIENTAL MERCHANTS, INC. (OMI) is a proud member of Rayomar Management Inc.'s group of companies. Rayomar, one of the country's progressive investment and management entity since 1982, has operation and ownership of several companies involved in shipping, crewing, logistics, freight forwarding and international trading.

Oriental Merchants, Inc. was established in 1988 as a trading company. As the name reveals, the company functions as a merchant from the orient which initially imported commercial products from Spain for the Philippine market. Later, OMI established it's export division which functions as the agent for various buyers from Europe, the US and Asia.

OMI is currently one of the most important importers and distributors of high quality Gourmet food products in demand by leading supermarkets, hotels and restaurants for quality brands from Spain, Portugal, Belgium and Italy. Products such as olive oils, canned vegetables, legumes, flavored vinegars, herbs and spices, cheese, pasta, seasonings, Portuguese Anchovies, canned tomatoes and biscuits. It has also non-food such as the personal care product lines: colognes, soaps, shampoos and body fresheners.

JOB RESPONSIBILITIES

• Act as Regulatory Affairs Officer for the company's food & cosmetic products.
• Coordinate with FDA for the acquisition of (1) License to Operate (LTO) for Food and Cosmetics as Importer/Distributor. (2) Certificate of product registration of food & cosmetic products. (3) Import Clearances for product samples included in upcoming new shipments.
• Coordinate with suppliers for all technical & other documentation needed.
• Review documents to make sure compliance is following FDA requirements.
• Monitor and update status of applied registrations, clearances & licenses.
• Organize and maintain the filling of product documents for FDA inspection purposes. Keep digital copies of all approved LTO, CPRS & accreditation.
• Provide the import department with the updated list of the product’s registered names to serve as a guide for the supplier’s shipping documents (invoice & packing list) to avoid problems with BOC clearances.
• Provide the Sales department with documents related to products quality and analysis data and manufacturers' certifications (GMP, ISO, HACCP, HALAL, KOSHER, etc).
• Arrange an inspection of office & warehouse facilities and participate during inspection for the renewal of LTO Food and Cosmetic.

QUALIFICATIONS

• Bachelor’s Degree in Pharmacy with valid PRC License.
• 2 to 3 years of working experience as an FDA regulatory officer.
• Knowledgeable with FDA, BPI & BOC regulatory compliances.
• Good verbal and written communication skills.
• Must be knowledgeable in MS Office.
• Willing to work in Muntinlupa City.