Manager, Regulatory Affairs

Manager, Regulatory Affairs

Supervises and participates in planning, preparing and evaluating regulatory documents for submission to governmental regulatory agencies including the U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, as well 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 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, specifically pre-application submissions (e.g., meeting requests), new application submissions (e.g., Investigational New Drug applications [IND], Biological License Applications [BLA], Orphan Drug applications [OD]), 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.
• 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 assures 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. 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.
• 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).
• Keeps abreast of new laws and regulations and assess impact on company products and processes. Alerts senior regulatory management of potential regulatory impact and implement appropriate internal changes. Contributes to the development of company policy and company positions on draft regulation and guidance.
• 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. Serves as project liaison corporate partners and regulatory agencies. Keeps corporate management and project team members abreast of regulatory submission deadlines and submission status.
• Ensures corporate policies and company procedures are in full and ongoing compliance with regulatory requirements.
• Provides direct or indirect supervision of individuals including mentoring, performance management and staffing decisions.
• Performs other projects, project-based tasks and/or special projects as assigned by senior regulatory management.
• Frequent contact with interdepartmental staff and management to exchange information, coordinate projects and problem solve.
• Regular contact with consultants and FDA representatives to exchange information and coordinate projects.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.

Qualifications

• Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Advanced degree desirable.
• 5+ years of pharmaceutical regulatory expertise across phases of drug development.
• Experience in Biologics and BLA submission is preferred.
• Effective written and verbal communication, collaboration, problem-solving, and negotiation skills.
• General knowledge of Good Manufacturing Practices, Good Clinical Practices, Good Documentation Practices, and Good Laboratory Practices.
• Excellent program management skills.
• Proficient in common office software applications.
• Must be able to represent the company with accuracy and sensitivity to regulatory issues.
• Detailed knowledge of laws and regulations, (specifically, US Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines), practices and international harmonization standards.
• Expert knowledge of Regulatory Affairs department SOPs.
• Must be able to balance multiple projects.
• Step-in to fill-in/take over ongoing projects with minimal notice.
• Multiple deadlines on conflicting projects with constant interruptions.
• Seven days travel per year required.