Chemist Consultant

Regulatory & Compliance

• Ensure all establishment operations meet the requirements of FDA-implemented laws, rules, and regulations.
• Guarantee that all health products manufactured, distributed, or sold satisfy the requirements of FDA-implemented laws, and that control systems are in place to prevent, eliminate, or reduce consumer risks.
• Ensure compliance with applicable standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices, Good Clinical Practices, and Good Distribution and Storage Practices (GDSP).
• Immediately report to the FDA any incident where a health product has caused adverse effects, serious illness, or injury, or contributed to a death.
• Immediately report and take action to recall, withdraw, seize, or ban any health product declared by the FDA to be injurious, unsafe, or dangerous.
• Declare the list of sources and suppliers for finished products, semi-finished goods, raw materials, and active pharmaceutical ingredients in applications. Notify the FDA of any changes to this list, as it is considered a minor variation.
• Collaborate with FDA authorities on actions taken for consumer protection.

Application & Documentation Management

• Ensure the establishment has a valid License to Operate (LTO) with the FDA before applying for other authorizations, like a Certificate of Product Registration (CPR) or a Certificate of Product Notification (CPN).
• Demonstrate compliance with standards appropriate to the establishment's authorized activities.
• Ensure that all documentary and technical requirements submitted in applications and amendments are true and correct.
• Inform the FDA of any changes or variations in the establishment's status or authorized activities by filing a major or minor variation application.
• Ensure compliance with applicable training related to the health products and establishments they are associated with.
• Ensure all required documents are available and presented during FDA inspections

Advisory & Quality Oversight

• Serve as a subject-matter expert on regulatory and technical requirements related to the supply chain.
• Ensure that the safety, efficacy, quality, and/or purity of any health product sold in its original, unopened packaging is maintained throughout the supply chain.
• Advise on compliance risks and corrective actions based on FDA findings.
• Support the development and maintenance of control systems to prevent, eliminate, or reduce consumer risks.

Qualifications

• Licensed Chemist
   with valid PRC license.
• Solid knowledge of 
  FDA laws, rules, and regulations
   governing health products and establishments.
• Familiarity with 
  GMP, GLP, GCP, and GDSP standards
  , including application in manufacturing, storage, and distribution.
• Strong background in 
  regulatory submissions, documentation, and variation applications
   with the FDA.
• Experience in 
  compliance oversight, risk assessment, and corrective action implementation
   to ensure product safety and consumer protection.