Regulatory Affairs Associate

Summary: 

The Regulatory Affairs Associate will provide guidance to Plasma Centers to ensure compliance with FDA regulations, guidance, and applicable international requirements. This role involves coordinating communications to complete government-mandated tasks, such as lookbacks and Biological Product Deviation Reports (BPDRs), between Center Managers, other departments, customers, and regulators to facilitate information sharing and resolve issues.

Responsibilities:

• Provide guidance to Plasma Centers on compliance with FDA regulations and international requirements.
• Coordinate communications for government-mandated tasks (e.g., lookbacks, BPDRs) between various stakeholders.
• Ensure timely and accurate processing and coordination of client lookbacks in line with regulatory requirements and customer specifications.
• Research and resolve discrepancies or missing information, and analyze final reports for accuracy.
• Serve as the primary contact for CLIA and COLA programs, providing guidance and assisting with audit and inspection responses.
• Evaluate Post Donation Information (PDI) and Error/Accident Reports (EAR) to determine if they meet the threshold for BPDRs, prepare and submit BPDRs to the FDA, and maintain related statistical data.
• Assess Plasma Center freezer temperature exposure incidents to determine necessary plasma relabeling and reporting to customers, and generate resolution letters.
• Assist with investigations related to DMS change requests, including donor number errors and test hold removals.
• Track incoming and outgoing paperwork to ensure FIFO processing, determine retention or disposal of information, and prioritize processing.
• Update departmental Standard Operating Procedures (SOPs) as required.

Requirements:

• Bachelor’s Degree required (pharmaceutical or biological sciences preferred). Equivalent experience may offset the degree requirement.
• Individual contributor
• 100% on-site in Boca Raton, Florida