Regulatory Affairs Manager

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, FL!

The Manager, Regulatory Affairs supervises and participates in planning, preparing and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA). Serves as an informative regulatory resource for cross-functional teams within ADMA. Provides regulatory guidance to address FDA questions for both investigational and market product applications. Ensures corporate policies, procedures and manufacturing/testing activities comply with regulatory requirements and approved INDs/BLAs.

• Provides accurate and timely regulatory guidance to all company functions while maintaining frequent contact with the Head of Regulatory Affairs.
• Performs other projects, project-based tasks and/or special projects as assigned by senior regulatory management.
• Provides direct or indirect supervision of individuals including mentoring and performance management.
• Ensures corporate policies and company procedures are in full and ongoing compliance with regulatory requirements.
• 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. Keeps corporate management and project team members abreast of regulatory submission deadlines and submission status.
• 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.
• 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).
• 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.
• Plans regulatory milestones, sets timelines and assures timely, accurate and complete submissions to regulatory agencies. Advises senior regulatory management of challenges to achieving timely, accurate or complete 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.
• Responsible for preparation, review, presentation, and evaluation of all regulatory submissions. Assesses 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], 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.

Education Requirements:

Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Master’s degree preferred.

Experience Requirements:

7-10 years' experience in Biologic Regulatory Affairs function with FDA, cGMP and cGCP experience. Experience with both personnel and project management. CBER and BLA experience is essential.

Effective written and verbal communication skills

• General knowledge of pharmaceutical development and federal regulations in pharmaceutical principles of document management.
• Excellent program management skills.
• Proficient in word processing packages.
• Must be able to represent the company with accuracy and sensitivity to regulatory issues.
• Detailed knowledge of: Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines; and Regulatory Affairs department SOPs.

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
• 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

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.