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Regulatory Affairs Pharmacist – Full‑time, On‑site

SYDENHAM Laboratories, Inc. · Dasmarinas

Onsite 🇬🇧 English
GMP ISO 9001 HACCP Documentation software

Job description

About the role

Sydenham Laboratories, Inc. is seeking a full‑time Regulatory Affairs Pharmacist to join its Dasmariñas facility. You will ensure that all product registrations, variations, and related documentation comply with national and international regulations.

Key responsibilities

  • Prepare, review, and submit registration dossiers and product variation applications.
  • Maintain up‑to‑date product licenses and monitor regulatory changes.
  • Ensure labeling, packaging, and promotional materials meet current regulatory requirements.
  • Collaborate with QA, production, R&D, and marketing to support product development and lifecycle management.
  • Manage regulatory documentation, respond to authority queries, and support audits and inspections.
  • Contribute to continuous improvement of regulatory processes and SOPs.

Required profile

  • Valid pharmacist license with a strong pharmacy foundation.
  • Experience in pharmaceutical, regulatory, or quality‑focused environments.
  • Demonstrated expertise in regulatory affairs and product registration.
  • Understanding of regulatory compliance for pharmaceuticals and food supplements.
  • Ability to work on‑site in Dasmariñas and thrive in a structured, process‑driven setting.

Required skills

  • Regulatory dossier preparation and submission
  • GMP knowledge
  • ISO 9001 familiarity
  • HACCP standards
  • Standard office and documentation software proficiency

What we offer

  • Opportunity to work in a PIC/S GMP‑compliant, ISO‑certified pharmaceutical company.
  • Collaborative environment with cross‑functional teams.
  • Professional growth in regulatory affairs within a legacy organization.

Questions fréquentes

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Published 3 months ago

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SYDENHAM Laboratories, Inc.

Dasmarinas