Regulatory Affairs Executive

2 days ago

Seri Kembangan, Selangor, Malaysia GOLD BILLION PHARMA SDN BHD Full time 60,000 - 100,800 per year

Requirements:

Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma in Food Science, Food Technology, Pharmacy, Engineering (Bioengineering/Biomedical) or a related field.

  • Required language(s): Bahasa Malaysia, Mandarin, English
  • At least 2 year(s) of working experience in the related field is required for this position.
  • Applicants must be willing to work in Serdang Perdana.

Tasks & responsibilities

1. Product Registration & Compliance
  • Ensure all products comply with regulatory requirements in targeted markets.
  • Prepare and submit product registrations, notifications, and approvals.
  • Handle FDA applications for multiple countries (e.g., US FDA, Philippines FDA, BPOM Indonesia, etc.).
  • Maintain up-to-date regulatory documentation and approval records.
2. Label & Claims Review
  • Review product labels, packaging, and marketing materials for regulatory accuracy.
  • Ensure product claims are compliant with relevant FDA or regulatory guidelines.
  • Verify supporting documents for all claims.
3. Ingredient & Formula Assessment
  • Check ingredients and formulations for compliance with country-specific regulations.
  • Confirm ingredient restrictions, permitted levels, and prohibited substances.
  • Work with R&D to ensure all formulations meet regulatory requirements before launch.
4. Quality & Safety Support
  • Coordinate required product testing, safety assessments, and laboratory analyses.
  • Prepare and compile documents needed for FDA or regulatory submissions.
  • Support the handling of product complaints and prepare regulatory reports when required.
5. Regulatory Monitoring
  • Monitor regulatory updates for botanical beverages, dietary supplements, and cosmetics.
  • Track changes from various country FDAs and relevant authorities.
  • Communicate updates and regulatory implications to internal teams.
6. Communication & Coordination
  • Liaise with FDA offices, government agencies, certification bodies, and external consultants.
  • Coordinate with internal teams (R&D, QA, Marketing, Production) on regulatory matters.
  • Provide regulatory guidance during product development and market expansion.
7. Documentation & Reporting
  • Maintain organized regulatory files, submissions, and technical documents.
  • Ensure all regulatory records are updated, accurate, and audit-ready.
  • Prepare regular reports on regulatory activities and product approval status.

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