Regulatory Pharmacist

Job Summary:

We are looking for a detail-oriented and proactive Regulatory Pharmacist to join our team. The position is responsible for ensuring that all company products comply with the regulatory requirements of the Food and Drug Administration (FDA) and other government agencies.

Key Responsibilities:

• Handle product registration, renewal, and other regulatory submissions to the FDA and other relevant agencies.
• Ensure compliance with all applicable medical device/supplies regulations.
• Prepare, review, and maintain regulatory documents, licenses, and certificates.
• Coordinate with internal departments for product documentation and compliance requirements.
• Monitor updates on regulatory guidelines and ensure the company’s adherence to all current standards.
• Liaise with FDA officers and inspectors during audits and inspections.

Qualifications:

• Licensed Pharmacist (with valid PRC license).
• Preferably with experience in FDA registration of medical supplies.
• Knowledgeable in regulatory documentation, compliance, and product registration processes.

• Strong communication and coordination skills.

Employment Type: Full-time