Compliance and Regulatory Officer

Sta. Ana Healthcare Plus Corp.; Pampanga; On-site; PHP 480,000 - 720,000; Full time

Benefits offered by this job

Performance Bonus

Health Insurance

Job Training

Job summary

A healthcare service provider in Pampanga is seeking a Regulatory Affairs Officer to manage licenses and ensure compliance with FDA and BOC regulations. The ideal candidate has a Bachelor’s degree in a related field and at least 1 year of regulatory experience. Responsibilities include coordinating inspections and maintaining documentation to meet regulatory standards. Strong analytical skills and attention to detail are essential. This role offers opportunities for professional development and health benefits.

Qualifications

• 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.
• At least 1 year of experience in 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.

Responsibilities

• Manage and renew company licenses and product registrations.
• Coordinate with FDA, BOC, and other regulatory authorities during inspections.
• Ensure all regulatory documents are accurate and compliant.
• Conduct compliance monitoring and assist in audit preparations.
• Review product packaging and labeling for 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.

Skills

Analytical skills

Communication skills

Organizational skills

Attention to detail

Education

Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, Life Sciences, or related field

Pharmaceutical Sciences

Regulatory Affairs

Life Sciences

Job description

Job Description

Employee Recognition and Rewards

Performance Bonus

Insurance Health & Wellness

Health Insurance

Professional Development

Job Training

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.