Associate Regulatory Affairs

Job DetailsJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category PharmaceuticalDescription

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart.  If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.  We currently have an exciting opportunity available for a Regulatory Affairs Associate!

The Regulatory Affairs Associate coordinate and execute ADMA Biologics lookback program.  Coordinate communications between State, CLIA and COLA programs with Center Management.  Contribute to compliance with FDA’s requirements for Biological Product Deviation Reporting.

Qualifications

Responsibilities:

• Provide guidance to Plasma Centers relating to Center compliance with FDA regulations/guidance's 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 to 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 in order 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 FDA.  Maintain statistical data relating to EARs/PDIs/BPDRs.
• Evaluate incidents of Plasma Center freezer temperature exposures for determination of 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 SOP’s as required.
• Filing, faxing, copying and mailing of paperwork and reports

 

• Education Requirements:  Bachelors Degree required. Degree can be offset by equivalent experience.         

 

• Experience Requirements: A minimum of 1 year experience in Plasma or  related field or FDA regulated industry with some laboratory and cGMP experience. Some general office experience helpful, typing and customer service; experience in plasma center operations preferred.

 

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance 
• Company paid STD and LTD
• Company Paid Holidays and Personal Days
• 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

Fast growing company. Redesigning HR of the future for ADMA. Benefit eligible on day 30. 100% paid dental, eye care, life insurance, STD and LTD.  75% employer paid medical with low premiums. PTO of 12 per year for first two years and then goes up from there, holidays, three floating holidays. 4% match 401k vested from day 1. Pet insurance with very low premium. 

Just awarded 2023 Best Places to Work!

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. 

ADMA Biologics is an Equal Opportunity Employer.