Associate Director, Regulatory Affairs - Plasma Services

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 Associate Director, Regulatory Affairs - Plasma Services in Boca Raton, Florida! 

The Associate Director, Regulatory Affairs - Plasma Services is responsible for the regulatory compliance of the Plasma Services Organization. Acts as the designated company authorized official for all communications with regulatory agencies regarding Plasma related issues. Supervises and participates in planning, preparing and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA). This position provides advice and direction regarding regulatory requirements.

• Be a versatile regulatory affairs department team member and produce work-product commensurate with professionalism and of the highest quality standards to submit to regulatory authorities for review and approvals. 
• Provides regulatory affairs guidance and support to Plasma Operations, Center Management, and Plasma Corporate staff to ensure regulatory compliance by Center facilities and Plasma organization.
• Reviews and interprets all applicable regulations governing Plasma processes and procedures to ensure full compliance.
• Ensures Plasma Centers are in compliance with all applicable governing regulatory agencies, assists with documentation for inspections and audits, provides insight and guidance for regulatory reporting and follow up of any 483’s or other identified issues; recommend corrective and preventive actions as necessary.
• Is available to regulatory authorities during inspections to ensure appropriate information is supplied as requested. Accompanies FDA inspectors for pre-scheduled new and routine center audits as directed.
• Prepares submission of Biologics License Applications (BLA's) associated to center establishments and plasma products and CLIA/COLA licensing as related to Plasma Center operations as directed.
• Prepares FDA Annual Report as it relates to the Plasma collection organization.
• Assists and collaborates with Plasma QA and Plasma Operations in the crafting audit and inspection responses.
• Provides regulatory affairs related consultation regarding Lookback, Post-Donation and Error/Accident, and BPDR situations as requested.
• Works with Plasma QA to notify FDA of any recalls and follows up with the FDA, other applicable regulatory agencies and customers as required, in accordance with the regulations and applicable laws.
• Aids in review from a regulatory affairs standpoint, of new and revised Plasma Center Standard Operating Procedures (SOP's), and review of related training materials with regard to applicable regulations to ensure compliance with applicable laws.
• Makes regulatory decisions and recommendations as applicable and required in collaboration with Regulatory Affairs and appropriate company leadership and other departments.
• Responsible for the preparation, review, presentation, and publishing of FDA submissions to assure accuracy and completeness of submission documents, which includes but is not limited to meeting requests/briefing packages and presentations to the FDA (e.g., preIND/pre-BLA, Type A,B or C, and advisory committee meetings), Investigational New Drug Applications (INDs), Biologic License Applications (BLAs), Marketing and Promotional Materials, Product Listing and Establishment License Applications, and other related documents or CMC supplement submissions as directed to support the company.
• Develops regulatory strategies, determin