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  b enefits   Please do not apply more than once. Thank you.