We are redirecting you to the source. If you are not redirected in 3 seconds, please click here.

Regulatory Specialist (Remote - US) at Jobgether. This position is posted by Jobgether on behalf of ObjectiveHealth. We are currently looking for a Regulatory Specialist in United States.. Join a dynamic team committed to advancing clinical research and improving patient outcomes through innovative processes and technology. In this role, you'll coordinate regulatory activities across multiple research sites, ensuring documentation compliance, GCP standards, and seamless communication with sponsors and internal teams. This position offers a high-impact opportunity to contribute directly to the quality and efficiency of clinical trials while growing your regulatory expertise in a supportive and fast-paced environment.. Accountabilities:. . Manage and maintain regulatory documentation throughout clinical trial lifecycles, including start-up and ongoing submissions.. . Ensure compliance with IRB protocols, HIPAA, sponsor requirements, and applicable regulatory standards such as GCP, FDA, and ICH guidelines.. . Prepare, submit, and track study-specific regulatory and training documentation, ensuring accuracy and timely updates.. . Maintain up-to-date credentials and documentation for physicians and key personnel, including CVs, licenses, and training records.. . Review and edit Informed Consent Forms for compliance with study protocols and regulatory requirements.. . Collaborate with investigators, research teams, and external sponsors to resolve issues and maintain open communication.. . Participate in audits, monitoring visits, and regulatory inspections, ensuring readiness and compliance.. . Deliver regulatory training to research staff and contribute to continuous process improvement.. . . Bachelor’s degree in life sciences, healthcare, or a related field is preferred.. . Minimum of 2 years’ experience in clinical research regulatory affairs or a similar function.. . Solid understanding of FDA regulations, GCP, ICH guidelines, and IRB operations.. . Strong organizational and multitasking skills with keen attention to detail.. . Excellent written and verbal communication abilities.. . Self-starter with the ability to work independently and meet deadlines in a fast-paced environment.. . Legal authorization to work in the US is required (no visa sponsorship available).. . Company Location: United States.