Regulatory Specialist

Position Overview:

The FDA Regulatory Officer is responsible for ensuring that the company's products, including cosmetics, food, medical devices, and drugs, meet FDA regulations and compliance standards. This position involves overseeing the preparation, submission, and maintenance of product registrations, monitoring regulatory requirements, and facilitating interactions with regulatory agencies. The officer ensures that all product-related documentation is accurate, up to date, and in compliance with FDA and international standards. Additionally, the role involves coordinating product testing, supporting product development, managing raw material inventories, and maintaining thorough and organized records.

Key Responsibilities:

1. Compliance with FDA Regulations:

2. Regulatory Oversight: Ensure all products are compliant with FDA regulations for their respective categories (cosmetics, food, medical devices, and drugs).

3. Product Registration Management: Oversee the timely and accurate registration of all products with FDA, ensuring registrations remain valid and up to date.
4. Standard Operating Procedures (SOPs): Develop, implement, and maintain SOPs for product registration and regulatory compliance across product lines.

5. Documentation Maintenance: Maintain regulatory files and documents, ensuring all product registration records are current, including:

   • Approved product labels.
   • Website product listings.
   • Government licenses and permits.
   • License and Product SOP requirements
   • Any other regulatory compliance-related documentation.
   • Document Preparation, Submission, and Tracking:

6. Application Preparation: Review, prepare, and process documentation for new product registrations and renewals of existing product licenses or applications.

7. Technical Review: Evaluate technical documents related to product safety, efficacy, and labeling to ensure compliance with regulatory requirements.
8. Submission to Regulatory Authorities: Prepare and submit applications, ensuring completeness and compliance with FDA and other relevant regulatory bodies.
9. Process payments for application fees and monitor status of applications.
10. Status Monitoring: Regularly track and report the status of product registration and application submissions to relevant departments and management.

11. Product Testing Coordination:

12. Sample Preparation and Submission: Coordinate the submission of product samples and necessary documentation for testing by accredited testing agencies.

13. Record Maintenance: Maintain organized and up-to-date records of all testing results, ensuring proper documentation for compliance and future reference.

14. International Regulatory Support:

15. International Compliance: Assist international clients with the product registration process in foreign markets, ensuring that all necessary documentation complies with local regulations.

16. Global Regulatory Files: Monitor, update, and maintain accurate records of international product registrations to ensure ongoing compliance in each jurisdiction.

17. Regulatory Communication:

18. Memoranda Issuance: Draft and issue memorandums regarding product registration changes, regulatory updates, and other related matters to internal teams and relevant stakeholders.

19. Regulatory Updates: Stay up-to-date with changes in FDA regulations and other regulatory bodies, ensuring timely communication of any changes that may affect product registration and compliance.

20. Product Development Support:

21. Market Research: Collaborate with the product development team to conduct market research and identify regulatory requirements for new products.

22. Cross-functional Collaboration: Work closely with marketing, technical, and manufacturing teams to ensure new products or modifications to existing products meet regulatory requirements before launch.
23. Regulatory Guidance: Provide regulatory guidance on packaging, labeling, and advertising to ensure compliance with FDA regulations.

24. Raw Material Management:

25. Supplier Coordination: Work with suppliers to ensure the timely and cost-effective acquisition of raw materials, ensuring compliance with quality standards and regulatory requirements.

26. Technical Documentation: Work closely with suppliers to ensure the timely provision of all necessary technical documentation for raw materials.

27. Bill of Materials (BOM) Management:

28. BOM Preparation and Maintenance: Develop and maintain up-to-date Bills of Materials for all products, ensuring accuracy and compliance with regulatory standards.

29. System Updates: Encode and manage BOMs in internal systems (e.g., Netsuite, SKU Vault) and ensure accurate, real-time data availability across departments.
30. Interdepartmental Communication: Communicate any changes or updates to the BOM to relevant departments promptly, ensuring alignment across production, quality control, and regulatory teams.

31. Technical Documentation and Filing:

32. Organized Documentation: Ensure that all technical documentation related to products, including compliance records, regulatory filings, testing results, and certifications, are maintained in an organized, accurate, and accessible manner.

33. Record-Keeping: Implement a system for the systematic organization of technical files to facilitate quick retrieval and future audits.

34. General Administrative and Additional Responsibilities:

35. Regulatory Updates: Monitor regulatory developments that might impact company products and processes.

36. Cross-Functional Support: Provide ongoing support to other departments (e.g., quality assurance, production, marketing) as needed for regulatory affairs and compliance.
37. Other Duties: Perform other relevant tasks and duties as assigned by the Regulatory Affairs Manager or senior leadership to support regulatory and compliance initiatives.

Qualifications:

• BS Pharmacy graduate
• At least 3-5 years of experience in FDA regulatory affairs or a related field
• Strong knowledge of FDA regulations for cosmetics, food, medical devices, and drugs
• Excellent organizational skills and attention to detail
• Strong communication skills, both written and verbal
• Ability to work independently and as part of a team
• Experience with product registration processes, document submission, and compliance management
• Familiarity with technical documentation and filing systems
• Full Time and office-based working schedule

Direct employment with the client

Location: Relumins Unit 5, 7th Floor 1741 Hexagon Corporate Center Quezon City

Monday to Friday/Dayshift: 9:00am to 6:00pm