Regulatory Support Specialist (Remote- India)

Confidential

Not specified permanent

Posted: May 14, 2026

Job Description

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

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