Apply for Regulatory Documents Assistant job at Indero CRO India. Freshers can apply. Remote and office-based positions available.
Company: Indero CRO
Position: Regulatory Documents Assistant
Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, or Life Sciences
Location: Remote/Office-Based (India)
Experience: 0–1 Years
Employment Type: Full-Time, Permanent
Industry: Clinical Research / Regulatory Affairs
Verified Job
Mode of Application: Online
About Indero CRO
Indero is a global Contract Research Organization (CRO) with a strong reputation in dermatology and rheumatology clinical trials. Since its establishment in 2000, Indero has consistently delivered high-quality clinical research solutions, earning the trust of leading pharmaceutical and biotechnology companies across North America, Europe, and Asia. Regulatory Documents Assistant Job at Indero CRO
The company’s focus lies in clinical excellence, regulatory compliance, and innovation in research operations. With offices in Montreal, Europe, and India, Indero continues to expand its global footprint by hiring skilled professionals who are passionate about clinical research and documentation. Regulatory Documents Assistant Job at Indero CRO
At Indero, employees thrive in a supportive, collaborative environment that encourages innovation, learning, and continuous career growth. The company strongly believes in fostering talent, promoting diversity, and empowering individuals to make meaningful contributions to global healthcare research. Regulatory Documents Assistant Job at Indero CRO
About the Role: Regulatory Documents Assistant (India)
The Regulatory Documents Assistant plays a critical role in maintaining the integrity and accuracy of regulatory documentation throughout the lifecycle of clinical trials. This position is ideal for fresh graduates in life sciences, pharmacy, or related fields who are eager to begin their career in clinical research and regulatory affairs.
As a Regulatory Documents Assistant at Indero CRO, you will support the Trial Master File (TMF) process, manage clinical documentation, and ensure compliance with ICH-GCP guidelines, company SOPs, and global regulatory standards.
This is a permanent, full-time opportunity available in both remote and office-based formats, giving candidates flexibility based on their location and preference.
Key Responsibilities
As part of Indero’s global regulatory team, your main responsibilities will include:
1. Trial Master File (TMF) Management
- Setting up and maintaining electronic and paper-based TMFs for assigned studies.
- Ensuring all essential trial documents are accurately filed, labeled, and updated.
- Tracking document versions and managing archiving processes in compliance with study timelines.
- Regulatory Documents Assistant Job at Indero CRO
2. Document Quality Review
- Reviewing regulatory documents to confirm accuracy, completeness, and compliance with ICH-GCP and internal SOPs.
- Identifying discrepancies or missing documents and coordinating with project teams for corrections.
- Conducting periodic TMF quality control reviews.
3. eTMF Oversight
- Assisting in setting up electronic Trial Master File (eTMF) systems.
- Supporting metadata entry, tracking, and validation of uploaded documents.
- Collaborating with Clinical Research Associates (CRAs) to maintain up-to-date document status.
4. Regulatory Compliance Support
- Reviewing site regulatory binders, ethics committee submissions, and essential site documents.
- Supporting the Regulatory Affairs team in preparing submission packages for global clinical trials.
- Maintaining awareness of local regulatory guidelines and GCP compliance requirements.
5. Administrative & Project Coordination
- Assisting in study material shipments, document tracking tools, and investigator communications.
- Supporting the Clinical Operations team with project documentation and coordination.
- Participating in internal audits and inspection readiness initiatives.
Eligibility Criteria
To qualify for this position, candidates must meet the following educational and professional criteria: Regulatory Documents Assistant Job at Indero CRO
Educational Qualification:
- Bachelor’s or Master’s degree in one of the following disciplines:
- Pharmacy (B.Pharm / M.Pharm)
- Pharmaceutical Sciences
- Life Sciences
- Biotechnology
- Microbiology
- Biochemistry
- Pharm.D or related fields
Experience:
- 0–1 years of experience in the pharmaceutical, CRO, or biotech industry.
- Freshers with knowledge of clinical trial processes are encouraged to apply.
Technical & Professional Skills:
- Understanding of clinical research operations, regulatory documentation, and Good Clinical Practice (GCP).
- Familiarity with Trial Master File (TMF) and eTMF systems (preferred).
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Excellent attention to detail and organizational skills.
- Strong written and verbal English communication skills (French language is a plus).
- Ability to multitask, work under pressure, and meet strict timelines.
Why Join Indero CRO?
Indero offers a supportive environment where your contributions directly impact global clinical research. Joining as a Regulatory Documents Assistant gives you access to: Regulatory Documents Assistant Job at Indero CRO
✅ 1. Career Growth Opportunities
- Gain hands-on experience in clinical documentation and regulatory compliance.
- Build a foundation for future roles in Regulatory Affairs, Clinical Operations, or Quality Assurance.
✅ 2. Global Exposure
- Work with international project teams and global clients from the US, Europe, and Asia.
- Learn the documentation standards followed by FDA, EMA, and Health Canada.
✅ 3. Employee Benefits
- Flexible work schedule for improved work-life balance.
- Permanent full-time role with job security.
- Comprehensive health and insurance benefits package.
- Training and development programs to enhance technical and regulatory skills.
- Collaborative and inclusive work culture focused on growth and innovation.
Work Environment & Company Culture
Indero believes that great research begins with great teams. Employees are encouraged to share ideas, learn from experts, and contribute to meaningful projects in the clinical research domain. Regulatory Documents Assistant Job at Indero CRO
The organization values:
- Integrity in documentation and data handling.
- Innovation in problem-solving and technology adoption.
- Collaboration across teams and geographies.
- Commitment to excellence in every clinical study.
Salary and Compensation
Indero offers a competitive compensation package based on qualifications and experience. Regulatory Documents Assistant Job at Indero CRO
- Expected Salary Range: ₹3,00,000 – ₹5,00,000 per annum.
- Additional Perks: Performance bonuses, paid leaves, health insurance, and flexible work arrangements.
Location Details
- Work Mode: Remote or Office-based (India)
- Office Location: Delhi, India (for office-based roles)
- Type: Full-Time, Permanent
Candidates preferring remote work will have access to all digital tools required for performing documentation tasks efficiently. Regulatory Documents Assistant Job at Indero CRO
How to Apply
If you are passionate about clinical research and regulatory documentation, apply now to become part of Indero CRO’s global team. Regulatory Documents Assistant Job at Indero CRO
Application Steps:
- Prepare your updated resume highlighting your education and relevant experience.
- Write a brief cover letter explaining why you are a good fit for this role.
- Submit your application via the official Indero CRO career portal or click the link below.
👉 Application Link – Apply Online
Ensure your application is submitted before October 30, 2025, to be considered for the first round of shortlisting. Regulatory Documents Assistant Job at Indero CRO
Important Dates
- Job Posted On: October 6, 2025
- Application Deadline: October 30, 2025
- Interview Mode: Online/Virtual
- Job Type: Permanent, Full-Time
Frequently Asked Questions (FAQs)
1. Who can apply for the Regulatory Documents Assistant role at Indero CRO?
Candidates with degrees in Pharmacy, Life Sciences, or related fields and 0–1 years of experience in clinical research or documentation can apply. Freshers are also welcome.
2. Is this a remote job?
Yes, this position is open for both remote and office-based applicants across India.
3. What skills are required for this job?
You should be proficient in Microsoft Office, have knowledge of clinical trial documentation, and understand GCP and regulatory compliance.
4. What is the selection process?
Shortlisted candidates will go through a resume screening, followed by a virtual interview with the regulatory and HR teams.
5. What is the salary range for this position?
The approximate salary range is ₹3–5 LPA, depending on education and experience.
Final Thoughts
The Regulatory Documents Assistant role at Indero CRO is a perfect opportunity for fresh graduates and early-career professionals looking to build a long-term career in clinical research and regulatory documentation. Regulatory Documents Assistant Job at Indero CRO
With a global presence, supportive culture, and focus on employee development, Indero offers the right platform to learn, grow, and contribute to life-changing medical research.
If you’re ready to step into the world of clinical research and make a difference — apply now and join Indero CRO today! Regulatory Documents Assistant Job at Indero CRO
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