ADMA Biologics, Inc. · 3 months ago
Associate, Regulatory Affairs
Boca Raton, FL
Full-time
Onsite
Entry Level
2+ years expADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. The Associate in Regulatory Affairs will be responsible for coordinating and executing compliance programs, ensuring adherence to FDA regulations, and facilitating communication between various stakeholders.
BiotechnologyHealth CareManufacturingMedical
No H1B
Responsibilities
Provide guidance to Plasma Centers regarding compliance with FDA regulations/guidance and applicable international requirements. Coordinate communications necessary to complete government-mandated tasks (e.g., lookbacks, Biological Product Deviation Reports) between Center Managers, other departments, customers, and regulators to facilitate information sharing and resolve problems
Responsible for timely and accurate processing and coordination of ADMA Biologics lookbacks consistent with regulatory requirements and customer specifications. Research discrepant/ missing information and analyze final reports for accuracy to provide accurate and timely information to customers
Serve as ADMA Biologics’ primary contact regarding CLIA and COLA programs. Provide guidance and assist in responses to audits and inspections
Evaluate Post Donation (PDI) and Error/Accident Reports (EAR) to determine if they meet the threshold of Biological Product Deviation Reports (BPDR) for reporting to the FDA. Prepare and submit BPDRs to the FDA. Maintain statistical data relating to EARs/PDIs/BPDRs
Evaluate Plasma Center freezer temperature exposure incidents to determine plasma relabeling and reporting to customers. Generate resolution letters for Plasma Center records
Assist with investigations related to DMS change requests, including donor number errors and test hold removals
Track incoming/outgoing paperwork to ensure FIFO processing; determine what information should be retained versus what should be discarded and prioritize processing
Update departmental SOPs as required
Filing, faxing, copying, and mailing of paperwork and reports
Qualification
Required
A minimum of 2 years of experience in Plasma or related field or FDA regulated industry with some laboratory and cGMP experience
Bachelor's Degree required. Degree can be offset by equivalent experience
Ability to follow the cGMP's and procedures with great attention to detail
Ability to understand and interpret government regulations and customer specifications
Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures
Able to work in high-pressure, deadline-driven environment
Preferred
Some general office experience helpful, typing and customer service; experience in plasma center operations preferred
Benefits
401K plan with employer match and immediate vesting
Medical, Vision, Life and Dental Insurance
Pet Insurance
Company paid STD and LTD
Company Paid Holidays
3 Weeks’ Paid Time Off (within the first year)
Tuition Assistance (after the first year)
Easily accessible to Tri-Rail
Free shuttle to the Boca Tri-Rail station
Company
ADMA Biologics, Inc.
ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.04BKey Investors
JP MorganAres ManagementHayfin Capital Management
2025-08-06Post Ipo Debt· $300M
2023-12-18Post Ipo Debt· $135M
2022-12-07Post Ipo Equity· $60M
Leadership Team
Adam Grossman
Founder, President & CEO
Recent News
MarketScreener
2026-01-05
2025-11-07
Company data provided by crunchbase