Regulatory Officer

JC Premiere Business International Inc.; Pasig; On-site; PHP 334,800 - 613,800; Full time

Benefits offered by this job

Health and wellness insurance

Life insurance

Employee discount

Job summary

A compliance-focused organization in Pasig seeks a Regulatory Officer to manage FDA licenses and ensure regulatory compliance. The ideal candidate should have at least 3 years of experience, a relevant Bachelor's degree, and strong organizational skills. Responsibilities include processing licenses, monitoring regulations, and supporting audits. The role offers government-mandated benefits including health insurance and employee discounts.

Qualifications

• Licensed professional (e.g., Pharmacist, Chemist, or other FDA-recognized license).
• At least 3 years of experience in FDA regulatory compliance and licensing.
• Experience handling FDA LTO, CPR, renewals, and regulatory documentation.

Responsibilities

• Process and manage FDA licenses and product registrations.
• Ensure timely renewal of FDA permits.
• Monitor FDA regulations and advisories for compliance.

Skills

Strong organizational skills

Regulatory compliance

Documentation skills

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology, Food Technology, Legal Management

Job description

Regulatory Officer – On-site, Pasig

3‑5 years experience, Bachelor’s degree, Full-time.

The Regulatory Officer is responsible for ensuring the company’s compliance with regulatory requirements set by the Food and Drug Administration (FDA). The role involves processing and maintaining licenses such as License to Operate (LTO) and Certificates of Product Registration (CPR), preparing and submitting regulatory documents, monitoring updates in FDA regulations, and coordinating inspections and audits. The Regulatory Officer also maintains accurate compliance records, supports internal audits, and ensures timely renewal of permits to prevent operational disruptions.

Responsibilities

• Process and manage FDA licenses and product registrations including License to Operate (LTO) and Certificate of Product Registration (CPR).
• Ensure timely renewal of FDA permits and maintain an updated compliance tracker.
• Monitor FDA regulations, advisories, and circulars to ensure company compliance.
• Prepare, submit, and follow up FDA applications and regulatory documents.
• Serve as the company representative during FDA transactions, inspections, and audits.
• Maintain accurate regulatory records and documentation.
• Address FDA findings and support implementation of corrective actions.
• Assist in developing and updating FDA-related policies and SOPs.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Food Technology, Legal Management, or related field.
• Licensed professional (e.g., Pharmacist, Chemist, or other FDA‑recognized license).
• At least 3 years of experience in FDA regulatory compliance and licensing.
• Experience handling FDA LTO, CPR, renewals, and regulatory documentation.
• Experience coordinating FDA inspections and audits.
• Strong organizational, documentation, and regulatory compliance skills.

NOTE: WE ARE SUBJECT FOR RELOCATION TO BGC ON APRIL

Benefits

Government mandated benefits include insurance health & wellness, life insurance, employee discount.