Regulatory Specialist

Job Description Insight Global is seeking a Regulatory Specialist to join the Clinical Research team at Hackensack Meridian Health in Hackensack, NJ. This contract role will support compliance and regulatory operations for clinical trials, ensuring adherence to institutional, federal, and sponsor requirements. The Regulatory Specialist will be responsible for preparing, submitting, and maintaining regulatory documents such as IRB submissions, amendments, and continuing reviews, while ensuring compliance with FDA, ICH-GCP, and institutional policies. Additional duties include maintaining accurate regulatory files, tracking essential documents in CTMS, and communicating with sponsors, CROs, and internal stakeholders regarding regulatory requirements. The role also involves assisting with audits and inspections, implementing corrective actions, and supporting protocol activation and ongoing trial maintenance. Candidates should have a bacheloru2019s degree in life sciences or a related field (masteru2019s preferred), at least 2u20133 years of experience in clinical research regulatory affairs, and strong knowledge of IRB processes, FDA regulations, and GCP guidelines. Proficiency with CTMS and document management systems, excellent organizational and communication skills, and the ability to manage multiple studies and deadlines in a fast-paced environment are essential. This 40 hours a week, on-site position. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements Bacheloru2019s degree in life sciences or related field (Masteru2019s preferred). Minimum 2u20133 years of experience in clinical research regulatory affairs. Strong knowledge of IRB processes, FDA regulations, and GCP guidelines. Proficiency with CTMS and document management systems. Excellent organizational and communication skills. Ability to manage multiple studies and deadlines in a fast-paced environment.

Created: 2026-01-28