Associate, Regulatory Affairs

Job Details
Job Description
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 an
Job Title: Associate, Regulatory Affairs
Job Description:
Position Summary
Responsible for coordinating and executing 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.
Essential Functions (ES) and 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.

Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detailAbility to understand and interpret government regulations and customer specificationsAble to evaluate and interpret regulations and recognize the need for appropriate changes relative to proceduresAble to work in high-pressure, deadline-driven environmentExperience Requirements

• A minimum of 2 years of experience in Plasma or related field or FDA regulated industry with some laboratory and cGMP experience.

Education Requirements:

• Bachelor's Degree required. Degree can be offset by equivalent experience.

Preferred Experience

• Some general office experience helpful, typing and customer service; experience in plasma center operations preferred.

Compliance Requirements (ES) The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.Job Description Footer:
In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA 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 .
ADMA Biologics is an Equal Opportunity Employer.
Company
ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.
Company info
Website Phone Location 5800 Park of Commerce Blvd. NW
Boca Raton, FL 33487
US
Share this job

• Facebook
• Twitter
• LinkedIn