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Regulatory Affairs Manager

1 week ago

Manila, National Capital Region, Philippines sbsph Full time

About the Job

This role requires a highly qualified Regulatory Pharmacist to work closely with the Regulatory Head and Management team to ensure compliance with regulatory requirements related to the importation, distribution, and sale of chemical, pharmaceutical, and medical products.

Key Responsibilities

  1. Function as the Company Pharmacist of SBS Philippines Corporation.
  2. Handle the overall legal requirements of the company's application to FDA's CDRR, CFRR, and CDRRHR under Ulife Corporation.
  3. Ensure that LTOs and CPRs and other documents needed for FDA application and inspection are updated and valid.
  4. Represent the Company during FDA inspections.
  5. Update the master list of products and filing of CPRs.
  6. Maintain an organized file and records for management of the authenticated and other important documents.