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:

• Minimum of 5-7 years of experience in regulatory affairs within clinical research, with strong knowledge of FDA regulations, ICH-GCP guidelines, and regulatory requirements.
• Prior experience managing and mentoring regulatory staff within a clinical or regulatory environment.

Requirements:

• Knowledge of medical terminology
• Understanding the principles of administration

Education:

• High School Diploma required, Bachelor’s degree preferred.
• Two years of on-the-job training as a Regulatory Coordinator.
• Association of Clinical Research Professionals (ACRP) certificate preferred.
• Society of Clinical Research Associates (SOCRA) certificate preferred.

Continuing Education:

• IATA (dangerous goods handling)
• GCP (good clinical practice)

Competency Requirements:

• Excellent written and verbal communication skills
• Excellent analytical and problem-solving skills
• Strategic planning and organizational skills, with the ability to manage multiple projects simultaneously across a network.
• Proficient with Microsoft Office (or similar software) and CTMS platforms
• High level of personal motivation and initiative.

Technical Competency Requirements:

• In-depth knowledge of ICH/GCP guidelines for human research and understanding of CFR regulations.
• Familiarity with CTMS platforms, EDC systems, and both electronic and hard-copy documentation management.
• Extensive knowledge of government regulations relevant to clinical research.
• Understanding of Phases I-IV drug development processes.
• Ability to educate and inform management on regulatory compliance requirements.
• Proficiency in Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) planning for ongoing compliance improvements.

Physical Requirements and/or environmental factors:

• Prolonged periods of sitting, standing or walking as required by the job.
• Ability to lift up to 20 pounds, and occasionally more.
• Occasional travel to company sites, investigator meetings, and sponsor-required meetings.
• Remote work flexibility with occasional night and weekend hours.

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.