"Regulatory Document / eTMF Specialist Hiring for US Clinical Trials | CRO Jobs India 2026"

(Regulatory Document / eTMF Specialist Hiring for US Clinical Trials)

Introduction

If you are an experienced professional in clinical research documentation, eTMF management, or regulatory compliance, and are looking to work on US-based clinical trials, this opportunity can take your career to the next level. A growing Clinical Research Organisation (CRO) is currently hiring Regulatory Document / eTMF Specialists with hands-on experience in study start-up, regulatory submissions, TMF/ISF management, QC, QA, and regulatory audits.

This role is specially designed for professionals who are passionate about clinical trial compliance, document quality, and US FDA regulatory standards. With exposure to global trials and flexible working options, this position offers both stability and long-term career growth in the clinical research domain.

About the Company (Company Introduction)

The hiring organisation is a fast-growing Clinical Research Organisation (CRO) involved in managing and supporting US-based clinical trials across multiple therapeutic areas. The company focuses on regulatory excellence, data integrity, and ICH-GCP compliance, helping sponsors successfully execute clinical studies under strict FDA-regulated environments.

Company Highlights:

• Industry: Clinical Research / CRO

• Focus Area: US FDA–regulated clinical trials

• Headquarters: India

• Founded: 2018

• Employees: 150+ clinical research professionals

• Work Model: Remote / On-site / Hybrid (project-based)

The organisation promotes a professional, quality-driven work culture with a strong emphasis on training, compliance, and career progression.

Job Overview Summary

The Regulatory Document / eTMF Specialist will play a critical role in managing and maintaining Trial Master Files (TMF) and Investigator Site Files (ISF) for US clinical trials. The position involves close collaboration with study teams, sponsors, and auditors to ensure that all regulatory documentation meets FDA, ICH-GCP, and sponsor requirements.

This role is ideal for candidates with 2+ years of experience in regulatory documentation, eTMF systems, and audit support within a CRO or clinical research environment.

Vacancy Details (Official)

• Position: Regulatory Document / eTMF Specialist

• Industry: Clinical Research / CRO

• Studies: US-Based Clinical Trials

• Experience Required: Minimum 2+ Years

• Job Location: India (Remote / On-site as per project needs)

• Employment Type: Full-Time

Job Role & Responsibility Explanation 

As a Regulatory Document / eTMF Specialist, your key responsibilities will include:

• Supporting study start-up activities, including feasibility and site initiation processes

• Assisting in site selection and regulatory packet preparation

• Maintaining TMF and ISF in line with ICH-GCP and sponsor requirements

• Performing Quality Control (QC) checks on regulatory documents before submission

• Conducting Quality Assurance (QA) reviews to ensure document accuracy and completeness

• Supporting internal and external audits, especially for US clinical trials

• Ensuring documentation readiness for FDA inspections and sponsor audits

• Managing electronic and paper-based regulatory documentation systems

Eligibility Criteria (Official)

Candidates must meet the following eligibility requirements:

• Minimum 2+ years of experience as a Regulatory Document Specialist or eTMF Specialist

• Experience working on US-based clinical trials

• Educational background in:

  • Life Sciences

  • Pharmacy

  • Clinical Research

  • Biotechnology or related discipline

Skills Required 

To succeed in this role, candidates should possess:

• Strong understanding of ICH-GCP and FDA regulations

• Hands-on experience with TMF / eTMF systems

• Expertise in QC and QA of clinical trial documents

• Excellent attention to detail and documentation accuracy

• Ability to manage multiple studies simultaneously

• Strong written and verbal communication skills

• Audit-ready mindset and compliance-focused approach

Salary Estimate (Unique)

Based on current CRO industry standards in India:

• Estimated Salary Range: ₹4,00,000 – ₹8,00,000 per annum

• Salary will depend on experience, skill level, and exposure to US clinical trials

Additional benefits may include flexible working options, training programs, and performance-based growth.

Interview Details (Official)

• Interview Mode: Virtual / Telephonic

• Interview Process:

  • Resume Shortlisting

  • Technical Interview

  • Final HR Discussion

• Interview Call: Only shortlisted candidates will be contacted

Required Documents 

Candidates should keep the following documents ready:

• Updated Resume / CV

• Experience Certificates

• Educational Qualification Certificates

• Government ID Proof

• Any relevant clinical research training certificates

How to Apply 

Interested and eligible candidates can apply via email:

📧 Email ID: CV@youvresearch.com
📌 Subject Line: Document/eTMF Specialist Application

👉 Apply early to increase your chances of shortlisting.

FAQs Section (Unique)

Q1. Is this job suitable for freshers?

No, this role requires a minimum of 2+ years of experience in regulatory documentation or eTMF.

Q2. Is the job completely remote?

Work mode depends on project requirements and may be remote or on-site.

Q3. Are these US clinical trials?

Yes, the role primarily supports US FDA-regulated clinical trials.

Q4. What background is preferred?

Life Sciences, Pharmacy, Clinical Research, or related fields are preferred.

Final Conclusion

If you are looking to strengthen your career in clinical research compliance and regulatory documentation, this Regulatory Document / eTMF Specialist role offers excellent exposure to US clinical trials, global regulatory standards, and long-term career growth. With flexible working options and a compliance-driven culture, this opportunity is ideal for experienced professionals aiming to advance in the CRO industry.

Stay connected with Pharma Duniya for trusted and latest clinical research job updates across India.

Note: Pharma Duniya does not charge any money for job information.
Candidates are advised to verify details from the official company website.

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