Manager, Regulatory Affairs

Role Summary

Supervises and participates in planning, preparing and evaluating regulatory documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, and acts as an informative regulatory resource for cross-functional teams. 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 the 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 submissions, INDs, BLAs, Orphan Drug applications, maintenance submissions, post-marketing submissions, and other related documents or 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 ensures 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. Improves regulatory processes by reviewing, writing and revising policies, SOPs and work instructions that ensure efficient and compliant regulatory processes.
• Works closely with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices. Uses problem solving to recommend risk mitigation strategies and 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 positions on draft regulation and guidance.
• Serves on project teams to contribute regulatory guidance for investigational and marketed products, regulatory strategy and to ensure appropriate and feasible strategies are explored. Serves as project liaison with corporate partners and regulatory agencies. Keeps management and project team members informed of submission deadlines and status.

Qualifications

• Required: Minimum of 7 years of practical pharmaceutical regulatory expertise across phases of drug development.
• Required: Minimum of 5 years’ experience with Master’s degree.
• Preferred: Effective written and verbal communication, collaboration, problem-solving, and negotiation skills.
• Preferred: General knowledge of Good Manufacturing Practices, Good Clinical Practices, Good Documentation Practices, and Good Laboratory Practices.
• Preferred: Excellent program management skills.
• Preferred: Proficient in common office software applications.
• Preferred: Must be able to represent ADMA Biologics with accuracy and sensitivity to regulatory issues.
• Preferred: Detailed knowledge of laws and regulations (US Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines) and international harmonization standards.
• Preferred: Expert knowledge of Regulatory Affairs department SOPs.
• Preferred: Must be able to balance multiple projects.
• Preferred: Step-in to fill-in/take over ongoing projects with minimal notice.
• Preferred: Manage multiple deadlines on conflicting projects with constant interruptions.

Skills

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

Education

• Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Advanced degree desirable.

Additional Requirements

• Compliance with ADMA Quality policies, standards and SOPs in their area of work; ensure QA records, HR policies, and EH&S procedures and practices are completed in a timely manner; escalate issues to QA, HR or EH&S as appropriate.