Manager, Regulatory

Role Overview: You will be responsible for managing a team of regulatory specialists and ensuring timely regulatory submissions to support study start up. As a Manager at Velocity Clinical Research, you will proactively address challenges, drive efficiency, and provide guidance on regulatory compliance. Key Responsibilities: - Manage a team of regulatory specialists to ensure timely and efficient regulatory submissions. - Prepare study-specific documents such as protocols, informed consent forms, and HIPAA authorizations for review by the IRB. - Submit and manage amendments, adverse event reports, and other IRB-required submissions. - Provide guidance on conflict of interest paperwork and maintenance of study binders. - Identify gaps in study start-up and address potential vulnerabilities. - Develop regular reporting for executive management to demonstrate study start-up progress. - Coordinate meetings with auditors and inspectors to review regulatory files. - Stay updated on evolving regulatory trends and ensure compliance with changes in regulations. - Maintain binder accuracy, completeness, and inspection readiness. - Submit generic site material to the Velocity IRB. - Perform other duties as assigned. Qualifications Required: - Proficiency in using computers, Microsoft Office software, fax, copier, and multi-line telephone. - Strong organizational, interpersonal, and communication skills. - Ability to work in a fast-paced environment and as a team player. - Excellent written and verbal English language skills. - Demonstrated ability to multitask, mentor, and train others. - Detail-oriented with strong problem-solving and decision-making skills. - Understanding of ICH, GCP, and FDA regulatory requirements. - High School Graduate and/or technical degree required; Bachelor's degree or Associate's degree preferred. - 4-6 years of clinical research regulatory experience preferred; 2-3 years of supervisory experience preferred. Note: The Job Description provided is a general outline of the position's function and is subject to change as per Company, department, and circumstance requirements. All employees are expected to perform their duties within their capacity and as requested by management.,