Manager, Regulatory Affairs

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 Manager, Regulatory Affairs in Boca Raton, Florida!

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 Manager, Regulatory Affairs in Boca Raton, Florida!

Job Title:

Manager, Regulatory Affairs

This is an onsite, in-person position located in Boca Raton, Florida.

The Manager, Regulatory Affairs, supervises and participates in planning, preparing and evaluating regulatory documents for submission to governmental regulatory agencies like U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, as well as an informative regulatory resource for cross-functional teams. Ensures corporate policies and procedures comply with regulatory requirements.

• Provides accurate and timely regulatory guidance to all company functions while maintaining frequent contact with Associate Director of Regulatory Affairs.
• Responsible for preparation, review, presentation, and evaluation of all regulatory submissions. Assess accuracy and completeness of submission documents throughout product lifecycle, specifically pre-application submissions (e.g., meeting requests), new application submissions (e.g., Investigational New Drug applications [IND], Biological License Applications [BLA], Orphan Drug applications [OD]), maintenance submissions (e.g., end-of-phase reports, annual reports, changes to IND or BLA Common technical Document [CTD] dossier, safety reports, product license renewals, establishment license renewals, meeting requests) and post-marketing submissions (e.g., annual reports, periodic safety reports, annual reports of Post-marketing requirements or commitments), and other related documents or submissions.
• Determines regulatory strategy that aligns with business strategy, defines submission requirements and coordinates the collection of required data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate.
• Plans regulatory milestones, sets timelines and assures timely, accurate and complete submissions to regulatory agencies. Provides signatory approval for reports and amendments or supplements to INDs or BLAs. Advises senior regulatory management of challenges to achieving timely, accurate or complete submissions.
• Oversees Regulatory Operations by developing or maintaining project timelines/milestones/submission tracking systems, and document archive systems. Practices regulatory process improvement by reviewing, writing and revising policies, standard operating procedures (SOP) and work instructions (WI) that ensure efficient and compliant regulatory processes.
• Works closely with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices. Utilizes problem solving skills to recommend risk mitigation strategies, and to develop alternative courses of action or contingency plans.

• Education Requirements:
  
  Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Advanced degree desirable.
• Experience Requirements:
  Minimum of 7 years of practical pharmaceutical regulatory expertise across phases of drug development.

• Minimum of 5 years' experience with Master’s degree.
• Effective written and verbal communication, collaboration, problem-solving, and negotiation skills.
• General knowledge of Good Manufacturing…