Regulatory Officer

Job Description

The Regulatory Officer ensures that the company's products, processes, and practices comply with all applicable government regulations, industry standards, and internal policies. This role will focus on securing product registrations, managing compliance documentation, liaising with regulatory authorities, and ensuring smooth market approvals.

Key Responsibilities:

Regulatory Compliance

-Ensure compliance with all relevant local and international laws, particularly FDA (Philippines), DOH, and other regulatory bodies.

-Monitor and interpret regulatory requirements, updates, and changes, ensuring timely internal communication and alignment.

-Serve as the primary contact for government agencies and regulatory bodies.

Product Registration & Documentation

-Prepare, compile, and submit product dossiers for approvals and renewals.

-Maintain updated records of licenses, permits, and regulatory approvals

-Maintain regulatory databases, licenses, and certificates, ensuring all are current and available for audit.

Liaison & Coordination

-Act as the primary contact with government regulatory agencies and industry associations.

-Coordinate with internal teams (R&D, Operations, Quality, Marketing) to ensure timely and compliant product launches.

-Monitor and interpret new regulations, policies, and industry standards; communicate changes to management and staff.

Policy & Process Development

-Draft, review, and implement internal compliance policies and standard operating procedures.

-Provide training and guidance to staff on compliance and regulatory matters.

Risk Management

-Identify and evaluate compliance risks, proposing preventive and corrective actions.

-Support audits and inspections, ensuring timely resolution of regulatory findings.

Job Qualifications

Qualifications:

-Bachelor's degree in Pharmacy, Chemistry, Biology, Regulatory Affairs, or related field.

-At least 2–3 years of experience in regulatory affairs or compliance (cosmetics, pharmaceuticals, or FMCG preferred).

-Familiarity with Philippine FDA processes, labeling requirements, and product registration.

-Strong organizational and documentation skills.

-Excellent communication skills for liaising with authorities and cross-functional teams.

Preferred Skills:

-Knowledge of international regulatory frameworks (ASEAN, EU, US FDA) is an advantage.

-Strong attention to detail and ability to manage multiple deadlines.

-Proactive, resourceful, and able to work independently with minimal supervision.