Manager, Regulatory Affairs

Role Summary

Manager, Regulatory Affairs at ADMA Biologics. Supervises and participates in planning, preparing and evaluating regulatory documents for submission to governmental regulatory agencies, serves as a liaison with regulatory agencies and contractors, and ensures corporate policies and procedures comply with regulatory requirements.

Responsibilities

• 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 across the product lifecycle, including INDs, BLAs, CTD dossiers, safety reports, and post-marketing submissions.
• Determines regulatory strategy that aligns with business strategy, defines submission requirements, and coordinates data/document collection from departments, facilities, affiliates, and contractors/vendors; liaises with partner companies as appropriate.
• Plans regulatory milestones, sets timelines, and ensures timely, accurate submissions; provides signatory approval for reports and amendments to INDs or BLAs; advises management on challenges.
• Oversees Regulatory Operations with project timelines, submission tracking systems, and document archives; improves regulatory processes through SOPs and work instructions.
• Works with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices; develops risk mitigation strategies and contingency plans.
• Oversees Biological Product Deviation reporting and product recall procedures (including notifications and corrections).
• Keeps abreast of new laws/regulations, assesses impact on products/processes, and contributes to policy development.
• Serves on project teams to provide regulatory guidance for investigational and marketed products; acts as liaison to corporate partners and regulatory agencies; communicates submission deadlines/status.

Qualifications

• Experience Requirements: Minimum of 7 years of practical pharmaceutical regulatory expertise across phases of drug development.
• Education Requirements: Bachelor‚Äôs degree in Pharmaceutical, Biological or Chemical Science or related field; advanced degree desirable.
• Minimum of 5 years‚Äô experience with Master‚Äôs degree.
• Preferred Experience: Strong written and verbal communication, collaboration, problem-solving, negotiation; knowledge of GMP, GCP, GDP, and GLP; program management skills; proficiency with Microsoft Office and project management tools; ability to balance multiple projects and work with tight deadlines; understanding of US FDA regulations and international harmonization standards.

Skills

• Regulatory strategy development
• Submission management (IND, BLA, CTD, post-marketing)
• Regulatory risk assessment
• Quality system liaison
• Project management
• Cross-functional collaboration
• Regulatory documentation and SOP development

Education

• Bachelor‚Äôs degree in Pharmaceutical, Biological or Chemical Science or related field; advanced degree desirable.

Additional Requirements

• None specified beyond standard regulatory compliance; travel or physical demands not stated as essential in the provided description.