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.