Regulatory Officer

2 weeks ago

Taguig, National Capital Region, Philippines The Coco Plus Goods Inc. Full time ₱1,200,000 - ₱1,800,000 per year

JOB SUMMARY

We are seeking a knowledgeable and detail-oriented Regulatory Officer to oversee and manage regulatory compliance and submissions to the Food and Drug Administration (FDA). This role is critical to ensuring that our products meet all regulatory standards and guidelines, and to support the timely registration, approval, and post-market compliance of our products.

JOB DESCRIPTION

  • Prepare, compile, and submit regulatory documents for FDA registration, renewal, and amendments for products (e.g., food, drugs, cosmetics, medical devices).
  • Monitor and interpret FDA regulations, guidelines, and policy changes to ensure ongoing compliance.
  • Maintain and update internal regulatory databases and documentation systems.
  • Liaise with the FDA and other relevant government agencies as needed to resolve regulatory queries or issues.
  • Work cross-functionally with R&D, manufacturing, and marketing team to ensure regulatory requirements are incorporated throughout the product lifecycle.
  • Ensure proper labeling, packaging, and promotional materials are compliant with applicable FDA regulations.
  • Assist in audits, inspections, and investigations by the FDA or other authorities.
  • Provide regulatory input during product development and formulation changes.
  • Keep current with local and international regulatory requirements affecting company operations.

JOB QUALIFICATION

  • Bachelor's degree in Nutrition, Pharmacy, Biology, Chemistry, or related field. A degree in law, regulatory affairs, or public health is an advantage.
  • At least 2-3 years of experience in regulatory affairs, preferably with direct FDA interaction.
  • Strong knowledge of FDA regulatory frameworks, such as RA 9711, FDA Circulars, and relevant IRRs.
  • Familiarity with product registration processes, e-submissions, and pharmacovigilance/reporting systems.
  • Excellent organizational and communication skills.
  • Attention to detail and ability to work independently under tight deadlines.
  • Proficiency in MS Office and regulatory databases/portals (e.g., FDA eServices Portal).

Job Type: Full-time

Pay: Php25, Php35,000.00 per month

Benefits:

  • Employee discount
  • Flexible schedule
  • Health insurance
  • Paid training
  • Promotion to permanent employee
  • Work from home

Experience:

  • Regulatory Affairs: 2 years (Required)

Work Location: In person

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