Regulatory Pharmacist

2 days ago

Fort Bonifacio P, Philippines ATC Healthcare Full time ₱336,000 per year

I. JOB SUMMARY

Acts as link between the company and the local regulatory authorities, ensuring compliance with FDA policies and guidelines and other government bodies.

II. DUTIES AND RESPONSIBILITIES

  1. Ensure product, LTO, and other government permits, and registrations are up to date and fully compliant.

  2. Compile registration dossiers for submission to FDA. Evaluate regulatory risk and strategy for proposed new products and ingredients. Manage, monitor and safekeeping of FDA filings.

  3. Manage and/or participate in inspections of company facilities by FDA and other applicable agencies.

  4. Liaise with different departments to address regulatory issues that impact compliance.

  5. Provide regulatory input on product and packaging development. Proof-read labels based on an understanding and interpretation of product formulas, contract provisions, account preferences and applicable regulation policies. Review and approve product claims intended for use in labeling and advertising, in accordance with regulatory requirements.

  6. Bear license holder responsibility.

  7. Participate in quality audits.

  8. Keep the company up to date with changes in regulatory legislation and guidelines.

  9. Provide information and training to concerned personnel with all matters relating to FDA regulations affecting product quality.

  10. Attend to government required lectures and seminars

  11. Manage and/or participate in the company's response to adverse event reports.

  12. Perform other tasks that may be assigned from time to time.

Job Type: Full-time

Pay: Php2, Php28,000.00 per month

Benefits:

  • Additional leave
  • Company Christmas gift
  • Company events
  • Employee discount
  • Flextime
  • Health insurance
  • Life insurance
  • Promotion to permanent employee
  • Staff meals provided

Work Location: In person

Expected Start Date: 11/28/2025

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