Regulatory Affairs Specialist

3 days ago

Caloocan, Philippines Exxel Prime Int'l Trading Inc. Full time

Overview

Job Title: Regulatory Affairs Specialist

Department: Technical Services

Reports To: Technical Services Manager

Location: #20 Corner Rose St., Reparo Rd., Barangay 161, Baesa, Caloocan City

Work Setup: On-site

Employment Type: Probationary (5 months)

The Regulatory Affairs Specialist is responsible for ensuring that all products of Exxel Prime Int’l 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.

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.
Qualifications
  • Graduate of BS Pharmacy, Chemistry, Biology, or other science-related courses.
  • At least 1 year of experience in regulatory affairs, product registration, or documentation compliance (experience in cosmetics or FMCG is an advantage).
  • Familiarity with Philippine regulatory bodies such as the FDA, DTI, BOC, and DENR.
  • Excellent written and verbal communication skills.
  • Highly organized, detail-oriented, and able to manage multiple tasks.
  • Proficient in MS Office and document management.
  • Must be willing to work on-site in Balintawak, Quezon City.

Fresh graduates with strong academic background and interest in regulatory work are welcome to apply.

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