Regulatory Affairs Specialist (FDA & Import Licensing), Quezon City

Position: Regulatory Officer

Reports to: FDA Liaison Supervisor

Department: Supply Chain

Job Summary

Supports the FDA Liaison Head in ensuring compliance with international and local regulatory standards.

Essential Duties and Responsibilities

1. Application & renewal of Certificate of Accreditation as Importer and other pertinent licenses.

a. Bureau of Customs for certificate to Import

b. FDA (Food and Drug Administration) for license as importer and license for retail stores

c. BAI (Bureau for Animal Industry) for Bow & Wow stores

d. Accreditation to NMIS(National Meat Inspection Service)

e. Accreditation to BPI (Bureau of Plant Industry)

2. Product Registration to FDA, BAI, NMIS, BPI and other concerned government agencies. As well as other applications needed in the importation of products (ex. Add Source, Permit to Import and the like)

3. Acts as the company representative during government inspections keeping the best interest of the customers and company in mind

4. Ensures that all retail stores have their own store pharmacist

5. Provides the documents required by FDA or other govt agency for newly opened retail stores

6. Maintains confidentiality of information and documents

Performance Indicators

1. Number Product Registrations

2. Timely renewal of CoA, LTO, and all relevant regulatory requirements

3. Timely, accurate and complete submission of reports

Qualifications

1. Nutrition or Pharmacy graduate

2. Exceptional negotiation and communication skills

3. Must be analytical and data-driven;

4. Able to multi-task, dynamic and flexible;

5. Honest and trustworthy;

6. Eager to embrace change;

7. Has effective interpersonal skills. Intuitive and personable;

8. Accessible; promotes teamwork and encourages feedback.