If you’re looking for Remote Clinical Research Jobs in India, Regulatory Affairs jobs, or Work From Home Clinical Operations jobs, Monroe Biomedical Research is hiring a Regulatory Support Specialist to support its U.S. clinical research operations. This fully remote opportunity is ideal for professionals with experience in clinical research, regulatory documentation, study start-up, and ICH-GCP compliance who want to work with international clinical teams.

This Regulatory Support Specialist Remote India job offers exposure to global clinical trials, FDA-compliant documentation, eRegulatory systems, and cross-functional collaboration while working remotely from anywhere in India.

Regulatory Support Specialist Job Overview

About Monroe Biomedical Research

Monroe Biomedical Research is a clinical research organization dedicated to advancing healthcare through high-quality clinical research. The organization supports global clinical studies while maintaining regulatory compliance, operational excellence, and efficient clinical trial execution.

Key Responsibilities

The selected candidate will support U.S.-based clinical research operations by performing regulatory and study start-up activities.

Regulatory Documentation

• Prepare and support IRB submissions
• Submit amendments and continuing reviews
• Maintain essential regulatory documents
• Organize and maintain electronic regulatory binders (eRegulatory)
• Track regulatory approvals, submission timelines, and document expirations
• Maintain audit-ready regulatory files

Study Documentation

• Collect and organize:
  • Investigator CVs
  • Medical licenses
  • Training records
  • Essential site documents
• Maintain regulatory tracking logs
• Support document reporting activities

Clinical Study Operations

• Assist with study start-up activities
• Support site activation documentation
• Ensure compliance with FDA regulations
• Follow ICH-GCP guidelines and internal SOPs
• Support audit and inspection readiness

Cross-Functional Collaboration

• Coordinate with U.S.-based regulatory teams
• Communicate regulatory updates
• Respond to documentation requests
• Support multiple clinical studies simultaneously

Required Qualifications

Candidates should possess:

• 1+ years of experience in:
  • Clinical Research
  • Regulatory Support
  • Healthcare Administration
• Excellent written and spoken English
• Strong organizational skills
• High attention to detail
• Ability to manage multiple deadlines
• Microsoft Word, Excel, and Outlook proficiency

Preferred Qualifications

Candidates with the following experience will have an advantage:

• U.S. Clinical Research Organization (CRO) experience
• FDA regulations
• ICH-GCP Guidelines
• CRIO eRegulatory System
• CTMS platforms
• EDC Systems
• Experience working with international remote teams

Work Schedule

• Fully Remote Position
• Applicants must reside in India
• Availability overlapping 3–5 hours of U.S. Eastern Time business hours
• Reliable high-speed internet required
• Professional home office setup required

Benefits

Monroe Biomedical Research offers:

• Fully Remote Work from Home
• Healthcare Benefits
• International Clinical Research Exposure
• Global Clinical Operations Experience
• Opportunity to work with U.S. Clinical Teams
• Professional Growth in Regulatory Affairs

Why Apply?

This Regulatory Support Specialist Remote India Job is an excellent opportunity for professionals looking to build a career in:

• Clinical Research
• Regulatory Affairs
• Study Start-Up
• Clinical Operations
• Remote CRO Jobs
• FDA Regulatory Compliance
• ICH-GCP Documentation

Professionals with experience in clinical trial documentation, regulatory submissions, eRegulatory systems, CTMS, and EDC platforms will find this role highly relevant.

How to Apply

Application Link