Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs – Boca Raton, FL ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. Our devotion to this underserved population fuels us, and our hands‑on approach to production and development sets us apart. Position Summary The Senior Manager, Regulatory Affairs supervises and participates in the planning, preparation, and interpretation of regulatory documents for submission to the U.S. Food and Drug Administration (FDA). The role serves as a liaison with regulatory agencies and affiliates, provides regulatory guidance to address FDA questions for both investigational and market product applications, and ensures corporate policies, procedures, and manufacturing/testing activities comply with regulatory requirements and approved INDs/BLAs. Essential Functions and Responsibilities Provide accurate and timely regulatory guidance to Management, Process Development, Analytical Development, Manufacturing, and Quality Assurance/Quality Control staff while maintaining frequent contact with the Head of Regulatory Affairs. Prepare, review, present, and publish all FDA submissions to assure accuracy and completeness, including meeting requests/briefing packages and presentations (preIND/pre‑BLA, end‑of‑phase II, Type A, B or C, advisory committee meetings), INDs, BLAs, Orphan Drug Applications, marketing and promotional materials, product listing and establishment license applications, and other related documents or CMC supplement submissions. Develop regulatory strategies, determine submission requirements, and request necessary data, information, and documentation from pertinent departments and SMEs; liaise with clients and CMOs as appropriate. Provide signatory approval for supplements and amendments to INDs/BLAs, ensuring submissions are completed within specified regulatory time limits. Review and approve all materials included in submissions for accuracy and completeness, such as stability, validation, and investigation reports, product testing data, and information packages prepared by SMEs. Act as an authorized official for the organization and correspond with regulatory agencies to discuss strategies and request FDA guidance; participate in audits and FDA inspections as necessary. Provide regulatory guidance regarding investigational and marketed products and support clients and affiliates as needed. Oversee Regulatory Operations by tracking submissions, post‑marketing requirements/commitments, and maintenance of investigational and marketing applications and SOPs; possess appropriate knowledge of eCTD format and submission software systems. Additional Essential Functions and Responsibilities Advise Management of potential regulatory risks and/or delays in submissions for investigational and marketed products. Participate in company projects, project‑based tasks, and special projects assigned by the Head of Regulatory Affairs. Review and evaluate change controls and critical deviations to determine regulatory impact and reporting requirements; prepare and submit Biological Product Deviation Reports as necessary. Advise Project Teams on regulatory requirements and serve as a project team member to ensure primary and alternate strategies are appropriately explored. Serve in advisory roles to project teams regarding regulatory requirements and strategy development; keep management and team members abreast of project status and adherence to deadlines. Ensure corporate policies and procedures are in full compliance with regulatory obligations. Serve as liaison with the FDA, company personnel, corporate partners, and other regulatory agencies to ensure regulatory activities are completed on time. Competencies Able to work in a high‑pressure, deadline‑driven environment. Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines. Exceptional organizational and communication skills. FDA adherence. Education and Experience Requirements Bachelor’s degree in Pharmaceutical, Biological, or Chemical Science or a related field. Ten-plus years of practical pharmaceutical development regulatory experience at a management level in Regulatory Affairs, with an emphasis on Biologics and BLA submission experience. Compliance Requirements Strict adherence to FDA regulations and company policies governing sales and marketing activities. Completion of required compliance training, accurate documentation of sales interactions, adherence to data privacy regulations, proactive participation in compliance reviews, prompt reporting of potential issues, and ongoing education to stay updated on relevant FDA regulations. Benefits 401(k) 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 ADMA Biologics is an Equal Opportunity Employer. #J-18808-Ljbffr ADMA Biologics, Inc.