Regulatory Affairs Manager

Summary : The Regulatory Affairs Manager is responsible for ensuring regulatory compliance across a network of clinical research sites. This role involves developing and implementing regulatory frameworks, managing documentation, and conducting internal audits to uphold quality standards and compliance with FDA, GCP, and ICH guidelines. The manager oversees all regulatory reporting, manages staff within the Regulatory Department, and collaborates with cross-functional teams to ensure adherence to regulatory requirements and company policies. Additionally, the Regulatory Affairs Manager performs Root Cause Analysis (RCA) and implements Corrective and Preventive Actions (CAPA) as needed, maintaining a proactive approach to quality assurance and continuous improvement in all regulatory processes.

Responsibilities : The Regulatory Affairs Manager :

• Complies with the Company’s handbooks, policies, and procedures.
• Participates in site and Regulatory meetings and contributes relevant input.
• Leads Regulatory and site meetings.
• Collaborates with the Quality Assurance and Control team to ensure SOPs are updated and aligned with regulatory standards.
• Implements strategies to ensure study activities comply with regulatory requirements, study protocols, and government regulations.
• Responds to information requests from regulatory bodies and manages timely submissions of applications, reports, and other documents to relevant agencies.
• Prepares, submits, and tracks applications, reports, and regulatory documents to relevant agencies.
• Oversees the maintenance of regulatory documentation in both electronic and hard-copy formats.
• Maintains current knowledge of applicable regulations and monitors regulatory affairs to understand the impact of regulatory changes on company operations.
• Reviews regulatory binders to ensure all documentation is accurate, complete, and in compliance with applicable regulatory requirements.
• Participates in study build-out.
• Maintains familiarity with study-specific portals for efficient access to study-related information.
• Ensures that all required calibrations are up to date, including those for crash carts, temperature monitoring devices, and certifications, to maintain compliance with regulatory standards.
• Develops and maintains professional relationships in federal, state, and local regulatory agencies.
• Implements and monitors quality standards for company operating and production procedures, providing ongoing guidance.
• Prepares and oversees internal clinical research site audits to assess quality compliance.
• Prepares for and manages external sponsor and regulatory audits and inspections.
• Implements or monitors complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Conducts Root Cause Analysis (RCA) and implements Corrective and Preventive Actions (CAPA) for regulatory findings, ensuring ongoing compliance and continuous improvement.
• Manages the Regulatory Department, by among other things :
• identifying hiring needs within the Department
• interviewing and training new employees
• planning, assigning, and directing work
• appraising performance
• rewarding and disciplining employees
• addressing complaints and resolving problems
• Provides ongoing training and support to both new and current staff members, ensuring they are well-versed in regulatory processes, company procedures, and industry best practices.
• Manages and oversees regulatory start up and compliance for all sites within the Network.
• Collects, manages, and reports on departmental KPIs.
• Manages and directs the workload of 2-5 regulatory coordinators.
• May perform Regulatory Coordinator duties and responsibilities at times as part of a team effort.
• Monitors, provides direction, and develops procedures regarding documentation that must be retained in hard-copy binders and documentation that may be retained on E-Reg (Note that maintenance of hard-copy binders may require occasional travel).
• Ensures proper retention and regular updates of training records, certifications, and CVs of research personnel.
• Develops and maintains CVs, training records, certifications, and other personnel documentation, ensuring they are regularly updated (every 24 months).
• Coordinates with operations teams regarding production design and development to ensure compliance with regulatory standards.
• Assists with the development of standards for the company’s operating and production procedures.
• Coordinate internal discoveries and depositions with legal department staff.
• Utilizes advanced Microsoft Suite skills (Word, Excel, PowerPoint, Outlook) for reporting, documentation, and presentations.
• Proficiently uses CTMS platforms, database, and compliance software to manage complex regulatory documentation and ensure efficient workflow.
• Maintains an understanding of EDC systems and supports electronic data capture processes.
• Occasional travel to Company sites, Investigator meetings, and / or Company meetings.
• Performs other miscellaneous job-related duties as assigned by their manager or other management members.

Experience :

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Continuing Education :

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Equal Opportunity : The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.