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.