Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs in Boca Raton, FL

ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. We are a dynamic, innovative, growing company that values excellence and integrity.

This onsite, in‑person position is located in Boca Raton, Florida. 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 provides guidance on FDA questions for both investigational and marketed products, ensuring corporate policies, procedures, and manufacturing/testing activities meet regulatory requirements and approved INDs/BLAs.

• Provides 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.
• Prepares, reviews, presents, and publishes all FDA submissions, ensuring accuracy and completeness of documents, including meeting requests, briefing packages, INDs, BLAs, Orphan Drug Applications, marketing materials, product listings, and CMC supplement submissions.
• Develops regulatory strategies, determines submission requirements, and coordinates data, information, and documentation from relevant departments and SMEs. Liaises with clients and Contract Manufacturing Organizations as appropriate.
• Provides signatory approval for supplements and amendments to INDs/BLAs, assuring submissions meet regulatory time limits. Reviews all materials for accuracy and completeness, including stability, validation, and investigation reports and product testing data.
• Acts as an authorized official for the organization, corresponding with regulatory agencies to discuss strategies and request FDA guidance. Participates in audits and FDA inspections as needed.
• Provides regulatory guidance regarding investigational and marketed products and supports clients and affiliates as required.
• Oversees Regulatory Operations by tracking submissions, post‑marketing requirements/commitments, and maintaining investigational and marketing applications and SOPs. Demonstrates appropriate knowledge of eCTD format and submission software systems.

• Advises Management of potential regulatory risks and delays for investigational and marketed products.
• Participates in company projects, project‑based tasks, and special projects assigned by the Head of Regulatory Affairs.
• Reviews and evaluates Change Controls and Critical Deviations to determine regulatory impact and reporting requirements, preparing Biological Product Deviation Reports as necessary.
• Advises Project Teams on regulatory requirements and serves as a team member to ensure strategies are appropriately explored.
• Serves in advisory roles to project teams regarding regulatory strategy development, keeping management and team members updated on project status and deadlines.
• Ensures corporate policies and procedures fully comply with regulatory obligations.
• Serves as a liaison with the FDA, company personnel, corporate partners, and other regulatory agencies to ensure timely completion of regulatory activities.

Education: Bachelor’s degree in Pharmaceutical, Biological, Chemical Science, or related field.

Experience: Ten or more years of practical pharmaceutical development regulatory experience at a management level, with emphasis on Biologics and BLA submission experience.

The minimum compliance expectation for this role is strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. The role also requires proactive participation in compliance reviews, prompt reporting of potential issues, and ongoing education to stay updated on relevant FDA regulations.

• 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)
• Easy access 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
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ADMA Biologics is an Equal Opportunity Employer.