Regulatory Affairs Specialist

Job Summary

To ensure compliance with state and federal licensing requirements, the full-time remote Regulatory Affairs Specialist will plan and execute regulatory activities related to the distribution of drugs, medical devices, and other regulated products while developing policies and procedures for licensing compliance.

Key responsibilities

• Determine requirements for obtaining and complying with state and federal licenses for regulated products
• Prepare and submit licensing applications and documents to regulatory agencies
• Research licensing requirements and develop improvements to processes related to compliance

Required qualifications

• Bachelor's degree or equivalent combination of education and experience
• At least 2 years of experience in regulatory affairs, licensing, quality assurance, or compliance
• Applied knowledge of state pharmacy laws, FDA regulations, and DSCSA
• Experience with Quality Management Systems and Document Control
• Intermediate skill level in Microsoft Office Suite