Regulatory Compliance Officer

6 days ago

Makati City, National Capital Region, Philippines The CORE Clinic- Center for Optimum Rejuvenation Full time

The Regulatory Compliance Officer shall lead regulatory compliance efforts and ensure products meet FDA and allied regulatory standards. The position supports the full product registration lifecycle, manages regulatory records, and collaborates with internal teams to ensure product, labeling, and marketing compliance.

Key Responsibilities

  • Assist in the end-to-end registration of nutraceutical products through the FDA e-portal.
  • Ensure product specifications, labels, and claims meet FDA and ASEAN requirements.
  • Review and recommend compliant content for product labels, marketing, and e-commerce materials.
  • Manage and respond to regulatory communications from the FDA (e.g., Case Clarifications, Label Submissions, Post-Market Surveillance, and Notices of Non-Compliance).
  • Maintain and organize regulatory documents (MSDS, COA, LOA, Order of Payment, etc.) for audit readiness.
  • Monitor Certificate of Product Notification (CPN), Certificate of Product Registration (CPRs), License to Operate (LTOs) expirations and assist in product renewals.
  • Stay updated on regulatory changes and propose compliance strategies.
  • Collaborate with Product Development, Regulatory Pharmacist, and Marketing teams on compliance requirements for new product launches.

Qualifications

  • Education: Bachelor of Science in Pharmacy.

  • Experience: Minimum of 1–2 years in regulatory affairs, preferably in the nutraceutical, retail, or e-commerce industry.

  • Technical Skills:

  • Proficient in using the FDA e-portal.
  • Familiar with ASEAN Cosmetic Directives.
  • Knowledgeable in creating and maintaining Product Information Files (PIFs).

Skills and Competencies

  • Solid understanding of regulatory processes.
  • Excellent attention to detail and organizational skills.
  • Strong project management and critical thinking abilities.
  • Proactive, accountable, and able to work independently.
  • Effective communication and teamwork skills.
  • Strong time management and multitasking capabilities.

Job Type: Full-time/part-time

Work Location: In person

Job Types: Full-time, Part-time

Pay: Php25, Php30,000.00 per month

Expected hours: 20 per week

Benefits:

  • Flexible schedule
  • Flextime
  • Paid training
  • Work from home

Work Location: In person

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