Manager, Regulatory Affairs

Job Title

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.

Supervises and participates in planning, preparing and evaluating regulatory documents for submission to governmental regulatory agencies like the 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, including pre‑application, new application, maintenance, and post‑marketing 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.
• Oversees the Biological Product Deviation reporting and product recall procedures (including notifications and corrections).
• Keeps abreast of new laws and regulations and assesses impact on company products and processes. Alerts senior regulatory management of potential regulatory impact and implements appropriate internal changes. Contributes to the development of company policy and company positions on draft regulation and guidance.
• Serves on project teams to contribute regulatory guidance for investigational and marketed products, regulatory strategy and to ensure that appropriate and feasible strategies are explored. Serves as project liaison corporate partners and regulatory agencies. Keeps corporate management and project team members abreast of regulatory submission deadlines and submission status.

• Ability to effectively manage staff.
• Ability to handle multiple priorities and tight deadlines.
• Understand concepts, requirements, and accounting issues for all business areas.
• Ability to follow the cGMP’s and procedures with great attention to detail.
• Ability to train and motivate employees at all levels within an organization.
• Knowledge of all Federal and State regulations including OSHA and CUA.
• Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project).

• Minimum of 7 years of practical pharmaceutical regulatory expertise across phases of drug development.
• Minimum of 5 years’ experience with Master’s degree.