Regulatory Affairs Specialist

Exxel Prime Int'l Trading Inc.

Caloocan City, Metro Manila
Permanent
Full-time

1 month ago

Job Title: Regulatory Affairs SpecialistDepartment: Technical ServicesReports To: Technical Services ManagerLocation: #20 Corner Rose St., Reparo Rd., Barangay 161, Baesa, Caloocan CityWork Setup: On-siteEmployment Type: Probationary (5 months)The Regulatory Affairs Specialist is responsible for ensuring that all products of Exxel Prime Intl Trading Inc., particularly OMG Cosmetics and ORO Socks, comply with the relevant regulatory and legal requirements. This includes securing necessary permits, registrations, and certifications from regulatory bodies such as the FDA, DTI, and BOC, as well as monitoring changes in regulations that may affect product compliance.Key Responsibilities:

Prepare and submit product registration documents (e.g., FDA CPRs, LTOs, DTI registrations).
Ensure compliance with local and international regulatory requirements for cosmetics, garments, and consumer products.
Maintain a regulatory database and track the status of licenses, registrations, and renewals.
Liaise with regulatory agencies (FDA, BOC, DTI, etc.) for inspections, updates, and clarifications.
Work with product development, purchasing, and QA/QC teams to ensure regulatory compliance throughout the product lifecycle.
Monitor changes in applicable laws and regulations and assess their impact on business operations.
Ensure accuracy and integrity of labels, product claims, and marketing materials from a regulatory standpoint.
Assist in the preparation of audit documents and respond to regulatory queries or notices.

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