pharmacist

1 day ago

Makati City, National Capital Region, Philippines Frontier Dental Products Corporation Full time ₱30,000 - ₱60,000 per year

Key Responsibilities:

Regulatory Compliance & Product Registration

  • Manage and oversee FDA product registration, renewals, amendments, and related submissions.
  • Prepare, compile, and review regulatory documents and technical dossiers for new and existing products.
  • Coordinate with the FDA and other regulatory bodies for updates, requirements, and compliance audits.
  • Ensure all product information, labels, and packaging meet regulatory and legal standards.

Documentation & Record Maintenance

  • Maintain and update master files, certificates, permits, and all FDA-related records at the office.
  • Ensure timely filing and proper archiving of regulatory documents for internal and external reference.
  • Monitor expiration of permits and licenses, and ensure timely renewals.

Compliance Oversight

  • Review and ensure that company operations adhere to Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
  • Conduct periodic compliance checks to verify adherence to regulatory standards.
  • Support internal audits and regulatory inspections as needed.

Technical & Administrative Support

  • Provide technical guidance to management and other departments on FDA-related matters.
  • Coordinate with the product development and purchasing teams to ensure new materials meet regulatory requirements.
  • Assist in the preparation of compliance reports and company submissions related to product safety and quality.

Qualifications:

  • Licensed Pharmacist (PRC Registered)
  • At least 1-3 years of relevant experience in FDA compliance, product registration, or regulatory affairs
  • Knowledgeable in FDA e-portal processes, product documentation, and regulatory filing systems
  • Excellent attention to detail and strong organizational skills
  • Good written and verbal communication skills
  • Able to work independently and maintain confidentiality
  • Proficient in Microsoft Office (Word, Excel, PowerPoint) and document management systems

Job Type: Full-time

Work Location: In person

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