Regulatory Affairs & Compliance Specialist

Rifemedica Corporation; Manila; On-site; PHP 350,000 - 550,000; Full time

Job summary

Rifemedica Corporation is seeking a Regulatory & Compliance Officer to manage regulatory requirements, government registrations, importation documentation, and overall compliance activities.

You will prepare FDA registrations, renewals, variations, and maintain certificates and product registrations; coordinate with FDA and other agencies; review labels, packaging, and promotional materials for regulatory compliance.

Qualifications

• Bachelor's degree in a related field as listed in the job ad.
• 1–3 years of regulatory affairs or compliance experience.
• Experience dealing with Philippine FDA is highly preferred.
• Experience with Bureau of Customs, PhilGEPS, EPDMS or other government systems is an advantage.
• Experience in pharmaceutical, medical device, cosmetics, or healthcare products is preferred.
• Strong knowledge of regulatory documentation and government compliance requirements.
• Proficient in Microsoft Word and Excel.
• Excellent organizational and documentation skills.
• Strong attention to detail and ability to meet deadlines.

Responsibilities

• Prepare, submit, and monitor FDA product registrations, renewals, variations, notifications, and other regulatory applications.
• Maintain and monitor FDA Certificates, Licenses, and product registrations.
• Coordinate with the FDA regarding applications, deficiencies, inquiries, inspections, and compliance matters.
• Review product labels, packaging, claims, technical documents, and promotional materials for regulatory compliance.
• Prepare and maintain regulatory dossiers and supporting documents.
• Monitor updates to FDA regulations, guidelines, circulars, and applicable laws.
• Assist in the preparation and monitoring of importation and customs documentation.
• Coordinate with customs brokers, freight forwarders, suppliers, and relevant government agencies.
• Manage and maintain the company's PhilGEPS registration and membership, including renewals and updates.
• Maintain a comprehensive regulatory and compliance monitoring system for the company.

Skills

Regulatory affairs

Compliance

Importation

Documentation

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology/ Medical Technology/ Life Sciences/ Business Administration

Tools

MS Office

Excel

Job description

Rifemedica Corporation is seeking a Regulatory & Compliance Officer to manage regulatory requirements, government registrations, importation documentation, and overall compliance activities.

You will prepare FDA registrations, renewals, variations, and maintain certificates and product registrations; coordinate with FDA and other agencies; review labels, packaging, and promotional materials for regulatory compliance.