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Regulatory Compliance Specialist

1 week ago

Manila, National Capital Region, Philippines sbsph Full time

Company Overview

sbsph.com is a leading importer, wholesaler, and distributor of chemical products serving various industries. Our goal is to provide a one-stop shop business solution for our customers' chemical requirements.

Job Description

We are seeking a highly qualified Regulatory Pharmacist to ensure compliance with regulatory requirements related to the importation, distribution, and sale of chemical, pharmaceutical, and medical products. The successful candidate will provide assistance regarding documentation and monitoring regulation of products in different government agencies.

Key Responsibilities and Accountabilities

  1. To function as the Company Pharmacist of SBS Philippines Corporation.
  2. Handles the overall legal requirements of the company's application to FDA's CDRR, CFRR, and CDRRHR under Ulife Corporation.
  3. Ensures that LTOs and CPRs and other documents needed for FDA application and inspection are updated and valid.
  4. Represents the Company during FDA inspections.
  5. Ensures that all applications are properly submitted until completely processed.
  6. Monitors and follow-ups the pending applications regularly.
  7. Prepares, evaluates, and submits documents for deficiencies, amendments, and other compliance.
  8. Handles licenses and permit registrations of the SBS Philippines Corporation in Bureau of Animal Industry.
  9. Assists the Regulatory Head on other Government Registrations under SBS Philippines Corporation.
  10. Informs the Regulatory Head of FDA updates.
  11. Updates the master list of products and filing of CPRs.
  12. Maintains an organized file and records for management of the authenticated and other important documents.