Regulatory Affairs Officer

2 weeks ago

Quezon City, National Capital Region, Philippines Cosmetix Unlimited Inc Full time $30,000 - $60,000 per year

Key Responsibilities:

1. Product Registration and Compliance

  • Prepare, submit, and monitor applications for product registration, renewal, and amendments with the Food and Drug Administration (FDA) and other relevant agencies.
  • Maintain an updated tracker of all regulatory documents, permits, and certificates.
  • Ensure product labels, packaging, and claims are compliant with current regulations.

2. Intellectual Property (IPO) Management

  • Handle filing, renewal, and maintenance of trademark and intellectual property registrations with the Intellectual Property Office (IPO).
  • Coordinate with external legal counsel or agencies for IP-related matters.
  • Monitor and safeguard the company's brand and trademark portfolio.

3. Importation and Customs Compliance

  • Prepare and secure necessary permits, clearances, and certifications for product importation.
  • Coordinate with the Bureau of Customs (BOC), brokers, and suppliers for import documentation and release of shipments.
  • Ensure all imported goods comply with labeling and regulatory requirements prior to distribution.

4. Documentation and Reporting

  • Maintain a comprehensive and organized regulatory database and filing system.
  • Prepare periodic reports on regulatory submissions, status updates, and compliance metrics.
  • Support audits and inspections conducted by government agencies.

5. Cross-Functional Coordination

  • Work closely with Supply Chain, Marketing, Quality Assurance, and Legal teams to ensure regulatory alignment in product lifecycle management.
  • Provide regulatory guidance in product development, packaging design, and advertising materials.
Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or any related course.
  • At least 1–2 years of experience in Regulatory Affairs or related field.
  • Knowledge of FDA regulations, IPO processes, and Customs procedures.
  • Strong attention to detail, analytical, and organizational skills.
  • Excellent communication and coordination abilities.

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