Regulatory Document eTMF Specialist

YOUV Research hiring Regulatory Document/eTMF Specialist

YOUV Research hiring Regulatory Document/eTMF Specialist in India. Life Sciences graduates with 2+ years clinical research experience.

YOUV Research is expanding its clinical research operations and inviting experienced professionals to apply for the Regulatory Document / eTMF Specialist role. This opportunity is suited for candidates with strong hands-on exposure to regulatory documentation, TMF management, and quality oversight in clinical research studies, particularly within US regulatory frameworks. The role offers direct involvement in study start-up activities, compliance-driven documentation, and audit-ready trial master file management across industry-leading research projects.

Company Overview

YOUV Research is a growing clinical research organization committed to delivering high-quality regulatory and operational support across global clinical trials. With a strong focus on compliance, documentation excellence, and process-driven research execution, YOUV Research supports sponsors and research partners in meeting stringent regulatory expectations.

The organization is known for its collaborative work culture, flexible career opportunities, and involvement in complex, high-impact clinical research projects. YOUV Research places strong emphasis on regulatory integrity, audit readiness, and adherence to international clinical research standards, making it an ideal environment for professionals looking to build long-term careers in regulatory operations and trial documentation.

By aligning regulatory precision with operational efficiency, YOUV Research contributes to the timely advancement of clinical development programs while maintaining the highest levels of data integrity and patient safety.

Job Role & Responsibilities

The Regulatory Document / eTMF Specialist will play a key role in managing, reviewing, and maintaining essential clinical trial documents throughout the study lifecycle. This position requires a detail-oriented professional with solid experience in regulatory submissions, TMF/ISF maintenance, and quality review processes.

Key Responsibilities

• Support study start-up activities including feasibility assessments and site initiation preparation
• Coordinate site selection activities and manage regulatory packet submissions
• Maintain Trial Master File (TMF) and Investigator Site File (ISF) in compliance with regulatory requirements
• Ensure accurate, timely, and audit-ready filing of essential documents within eTMF systems
• Perform Quality Control (QC) checks on regulatory documents prior to submission
• Conduct Quality Assurance (QA) reviews to ensure completeness, accuracy, and compliance
• Support internal and external audits within regulatory frameworks, including US-based clinical studies
• Ensure documentation aligns with ICH-GCP, sponsor SOPs, and applicable regulatory guidelines
• Collaborate with clinical operations, regulatory affairs, and quality teams to resolve documentation gaps
• Track document lifecycle status and support inspection readiness activities
• Contribute to continuous improvement of document management processes and workflows

This role is critical in ensuring regulatory compliance, inspection readiness, and smooth progression of clinical trials across global programs.

Eligibility / Qualifications

Educational Requirements

Candidates must possess a graduation degree or higher in Life Sciences or related disciplines.

Relevant Courses (comma-separated):
B.Pharmacy, M.Pharmacy, Pharm.D, B.Sc Life Sciences, M.Sc Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research

Experience Requirements

• Minimum 2+ years of experience in clinical research documentation or regulatory operations
• Hands-on experience with eTMF systems and TMF/ISF management
• Prior exposure to study start-up activities, regulatory submissions, and site documentation
• Experience supporting US-based clinical studies is mandatory

Required Skills

• Strong understanding of clinical trial documentation requirements
• Experience with Quality Control and Quality Assurance of regulatory documents
• Familiarity with ICH-GCP guidelines and regulatory frameworks
• Audit support experience within regulated clinical research environments
• High attention to detail and strong organizational skills
• Ability to work independently and within cross-functional teams
• Good written and verbal communication skills

Location & Salary

• Job Location: India (details to be discussed during selection process)
• Employment Type: Full-time

Application Process

Interested candidates should apply by sending their updated CV to the email address below:

CV@youvresearch.com

Subject Line: Document/eTMF Specialist Application

Frequently Asked Questions

Who can apply for this role?

Life Sciences graduates with at least 2 years of experience in regulatory documentation or eTMF management can apply.

Is experience with US-based studies required?

Yes. Auditing and documentation experience within US regulatory frameworks is mandatory.

What systems will I work with?

You will work with electronic Trial Master File (eTMF) and document management systems.

Is this a remote or on-site role?

Work location and flexibility will be discussed during the interview process.

How do I apply?

Send your CV to CV@youvresearch.com with the specified subject line.

Summary Table

Company	YOUV Research
Vacancies	Regulatory Document / eTMF Specialist
Required Education	B.Pharmacy, M.Pharmacy, Pharm.D, B.Sc, M.Sc Life Sciences
Experience	2+ Years