Regulatory Officer

4 days ago

Bacolor Pampanga, Philippines STA. ANA HEALTHCARE PLUS CORP. Full time
Regulatory Officer / Regulatory Pharmacist

Location: Bacolor, Pampanga | Full-Time

About the Role

We are looking for a Regulatory Officer to ensure company compliance with all regulatory requirements for medical devices, in-vitro diagnostics, pharmaceuticals, food, cosmetics, and household hazardous products. This role involves handling product registrations, renewals, and documentation, as well as coordinating with government agencies and foreign principals.


Key Responsibilities

  • Manage and renew company licenses and product registrations (LTO, CMDN/CMDR, CPR, BOC).
  • Coordinate with the FDA, BOC, and other regulatory authorities during inspections and audits.
  • Ensure all regulatory documents, permits, and certifications are accurate, up-to-date, and compliant.
  • Conduct compliance monitoring and assist in audit preparations.
  • Review product packaging and labeling to ensure alignment with FDA standards.
  • Maintain organized records of all regulatory files, certificates, and supplier documents.
  • Provide regulatory support to management, sales, and marketing teams.
  • Advise the company on compliance issues and assist with technical documentation for bids.
  • Stay informed on changes to regulatory requirements and ensure timely compliance.

Qualifications

  • Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, Life Sciences, or related field.
  • Licensed Pharmacist (RPh) preferred but not required.
  • At least 1 year of experience in the regulatory field, preferably in medical devices, diagnostics, or pharmaceuticals.
  • Knowledge of regulatory documentation, compliance processes, and FDA/BOC procedures.
  • Strong analytical, communication, and organizational skills.
  • High attention to detail and ability to manage multiple priorities.

Why Join Us?

  • Gain hands-on experience in the regulatory field of healthcare and medical devices.
  • Work in a dynamic environment with opportunities for professional growth.
  • Be part of a team that ensures product compliance and public safety.

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