Regulatory Support Specialist (Remote- India)
Department: Clinical Operations Reports to: Polly Turner, Regulatory & Study Start-Up Manager FLSA Status: Full-Time Location: Remote- India This is a fully remote position open to applicants currently residing anywhere in India. About Monroe Biomedical Research At Monroe Biomedical Research, we are committed to advancing healthcare through high-quality clinical research. As we continue to grow, we are seeking a highly organized and detail-oriented Regulatory Coordinator Assistant based in India to support our U.S. clinical research operations remotely. This role is ideal for someone who thrives in a fast-paced environment, enjoys process-driven work, and is passionate about accuracy, compliance, and operational excellence in clinical research.
Key Responsibilities
Regulatory Support Assist with preparation and submission of regulatory documents including: IRB submissions Amendments Continuing reviews Essential study documentation Maintain accurate and audit-ready electronic regulatory files (eRegulatory binders) Track submission timelines, approvals, expirations, and regulatory milestones Support collection and organization of: CVs Medical licenses Training documentation Site essential documents Compliance & Study Operations Support clinical study start-up and activation activities Ensure documentation aligns with FDA regulations, ICH-GCP guidelines, and company SOPs Assist with audit and inspection readiness activities Help maintain regulatory tracking logs and reporting tools Cross-Functional Collaboration Coordinate with U.S.-based clinical and regulatory teams Communicate regulatory updates and document requests in a timely manner Support operational efficiency across multiple clinical studies and sites
Qualifications
Required 1+ years of experience in clinical research, regulatory support, or healthcare administration preferred Strong written and verbal English communication skills High attention to detail and organizational ability Ability to manage multiple priorities in a deadline-driven environment Proficiency with Microsoft Office Suite (Word, Excel, Outlook) Preferred Experience supporting U.S.-based clinical research organizations or sites Familiarity with: FDA regulations ICH-GCP guidelines eRegulatory systems (such as CRIO) CTMS or EDC platforms Experience working remotely with international teams Work Schedule Remote position based in India Must have availability overlapping minimum 3-5 U.S. Eastern Time business hours Additional Information This position is open to applicants currently residing in India Applicants must have reliable high-speed internet and a professional remote work setup
Benefits
Heath care benefits Please do not apply more than once. Thank you.