Advertisement
Are you an experienced Regulatory Document or eTMF Specialist looking to advance your career in US clinical trials? A growing clinical research organization is hiring skilled professionals with hands-on expertise in study start-up, regulatory documentation, TMF/ISF management, QC, QA, and regulatory audits.
This role is ideal for candidates passionate about clinical research compliance, document quality, and regulatory excellence within a US FDA–regulated environment.
Job Overview
- Position: Regulatory Document / eTMF Specialist
- Experience Required: Minimum 2+ years
- Industry: Clinical Research / CRO
- Studies: US-based clinical trials
- Location: India (Remote/On-site as per project needs)
Key Responsibilities
As a Regulatory Document/eTMF Specialist, you will be responsible for:
Advertisement
- Managing study start-up activities, including feasibility assessments
- Supporting site selection and regulatory packet submissions
- Maintaining Trial Master File (TMF) and Investigator Site File (ISF) in compliance with ICH-GCP
- Performing Quality Control (QC) checks on regulatory documents prior to submission
- Conducting Quality Assurance (QA) reviews to ensure accuracy, completeness, and compliance
- Supporting and participating in internal and external audits for US clinical trials
- Ensuring regulatory documentation aligns with FDA, ICH-GCP, and sponsor requirements
Required Qualifications & Skills
To be successful in this role, candidates should have:
- Minimum 2+ years of experience as a Regulatory Document Specialist or eTMF Specialist
- Strong knowledge of clinical research regulations and documentation
- Hands-on experience with TMF/eTMF systems
- Proven expertise in QC and QA of regulatory documents
- Experience supporting US-based clinical trials and audits
- Excellent attention to detail and documentation skills
- Background in Life Sciences, Pharmacy, Clinical Research, or related fields
Why Join This Organization?
- Work on impactful US clinical research projects
- Opportunity for career growth and skill advancement
- Exposure to global regulatory standards
- Collaborative and professional work culture
- Flexible working options based on project needs
Salary & Compensation
- Estimated Salary Range: ₹4,00,000 – ₹8,00,000 per annum
- Salary will be commensurate with experience, skills, and project exposure
How to Apply
Interested and eligible candidates can apply by sending their updated CV to:
📧 CV@youvresearch.com
📌 Subject Line: Document/eTMF Specialist Application
Advertisement
