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.