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