Regulatory Specialist

1.) Registered Pharmacist for all licenses, certificates, and permits of Blaine Group of Companies.

2.) Copes with a 5-day regulatory closing and schedule deadline

3.) Reconcile records of regulatory and inter-company regulatory necessities;

4.) Verify, check, and maintain validities of LTOs, CPRs, CPNs, Permits of the ff

Regulatory Agencies:

- Food and Drug Administration

- Bureau of Animal Industry

- Philippine Drug Enforcement Agency

- Philippine National Police

- Fertilizer and Pesticide Agency (2022 onwards)

5.) Creates and submits monthly, semi-annual, and annual reports to the above-

mentioned Regulatory Agencies

6.) Check and sign dossiers for submission to Regulatory Agencies,

7.) Validate completeness of requirements as mandated by Regulatory Agency for

compliance,

8.) Checks completeness of requirements as mandated by Regulatory Agency for

compliance;

9.) Represents the Company on all Regulatory Bodies for accreditations and

compliances,

10.) Responds to customers' external regulatory issues.

11.) Check records of management and archiving of documents for regulatory

compliances.

12.) Recommends regulatory management measures,

13.) Creates, amends, and maintains Product Labels both for internal and external use

14.) Check records of management and archiving of documents for regulatory

Compliance

15.) Recommends regulatory management measures,

Requirements

Education:

A graduate of BS Pharmacy or equivalent is a primary requirement, with additional higher self-directed education of the same field or supervisory experience.

Years of Related Work Experience:

Preferably with 3-4 years of work relevant experience on regulatory.