Regulatory Lead (Support)

Prepare, maintain, and provide oversight of all research-related regulatory documents.
Populate and coordinate the entire process for the initial submission of regulatory documents to the IRB, sponsors, and state or federal regulatory offices, as necessary.
Compile study information and submit initial, continuing, and final reports to the IRB and/or sponsor.
Prepare applicable submission forms and submit updated documents, including but not limited to amendments, addenda, Investigator’s Brochures, safety information, FDA Form 1572s, and informed consent documents.
Accurately file and maintain all required logs within the appropriate regulatory repositories.
Assist with and manage the archiving of clinical trial documents and records.
Prepare for monitoring visits and audits.
Distribute, collect, process, and track Essential Site Regulatory Documents for all ongoing studies, including the collection of updated investigator, pharmacist, and nursing CVs, licenses, GCP, IATA, and training certificates, as applicable. This process applies to both paper and electronic files for each study site.
Maintain the confidentiality of study protocol information and Protected Health Information (PHI).
Create error-free written documents and reports (e.g., cover letters, notes to file, memoranda, etc.).
Perform all duties in a safe and prudent manner.
Perform all study-related duties in a timely and cost-effective manner while adhering to policies.

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field.
Minimum 2 years of clinical research regulatory experience.
Demonstrated experience with IRB submissions, amendments, continuing reviews, and study closeouts.
Strong working knowledge of ICH-GCP, FDA regulations, and informed consent requirements.
Experience maintaining regulatory binders and essential study documentation.
Proficiency with Microsoft Office and electronic document management systems.
Excellent organizational, communication, and time management skills.
Ability to manage multiple studies and deadlines in a fast-paced environment.
Ability to work at times US time zone.