In the ever-evolving world of pharmaceuticals and clinical research, quality documentation and regulatory compliance are essential. For professionals looking to step into impactful roles in these areas, Fortrea offers golden opportunities with its current openings for TMF Associate I and Regulatory Operations Assistant II across Bangalore and Pune. These verified job positions promise not just employment, but a career journey rooted in purpose, innovation, and global impact.
Let’s explore the roles, expectations, qualifications, and growth potential behind these exciting pharma opportunities.
🧾 Position 1: TMF Associate I – Based in Bangalore
Role Overview:
As a TMF (Trial Master File) Associate I, you’ll be responsible for managing electronic Trial Master Files (eTMF) and ensuring that clinical study documents are accurate, organized, and audit-ready. You’ll be playing a key role in maintaining the integrity of clinical research data, which supports drug development and regulatory approvals.
🔍 Key Responsibilities:
- Organize, classify, and review documents using tools like Smart Inbox and ARC systems.
- Conduct visual quality checks to ensure clarity, consistency, and compliance with regulatory standards.
- Maintain GCP and ICH-compliant TMF systems as per company SOPs.
- Identify operational challenges and ensure corrective actions are implemented swiftly.
- Participate in audits and help maintain documentation for inspection readiness.
- Collaborate across departments to ensure complete and timely documentation.
🎓 Educational & Experience Requirements:
- Education: Bachelor’s degree in Life Sciences, Clinical Research, Business, or related fields.
- Experience: Minimum of 6–12 months working within a clinical research environment.
- Preferred: Master’s degree or practical experience with electronic clinical systems.
🧠 Skills That Make You Stand Out:
- Familiarity with ICH-GCP guidelines, TMF structures, and regulatory documentation practices.
- Proficiency in Microsoft Office Suite, Adobe Acrobat, and eTMF platforms.
- High attention to detail and the ability to multitask in a dynamic work environment.
🌍 Work Environment & Travel:
- Based in Bangalore, this position requires minimal travel (less than 10%).
- Expect a collaborative, process-driven atmosphere with supportive leadership.
🧾 Position 2: Regulatory Operations Assistant II – Based in Pune (Hybrid Mode)
Role Overview:
In this role, you will assist in preparing regulatory submissions, documentation, and compliance reports. The Regulatory Operations Assistant II supports product lifecycle documentation and coordinates cross-functional communication for regulatory affairs.
🔍 Key Responsibilities:
- Compile and review CMC documents and regulatory submissions for various global markets.
- Update specifications for raw materials and packaging.
- Assist in managing global labeling, supplier documentation, and stability reports.
- Ensure that all processes align with international regulatory guidelines.
- Support business planning, change control systems, and import licensing documentation.
🎓 Educational & Experience Requirements:
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or an MBA with a healthcare focus.
- Experience: 1–2 years in the regulatory affairs or pharma manufacturing domain.
🧠 Required Skills & Knowledge:
- Understanding of regulatory compliance, change control processes, and pharmaceutical quality systems.
- Familiarity with CSV (Computer System Validation), global regulatory databases, and internal SOPs.
- Analytical skills to assess risk, compliance, and documentation quality.
🏢 Work Environment:
- The position is based in Pune, and follows a hybrid work model, offering flexibility and work-life balance.
- You’ll be collaborating with cross-functional teams both on-site and virtually, creating a dynamic, interactive workflow.
🌟 Why Work at Fortrea?
Fortrea is not just another clinical research company — it’s a global engine of innovation committed to advancing human health. Here’s what makes Fortrea stand out:
- ✅ Work-Life Balance: With minimal travel and hybrid options, Fortrea supports your well-being.
- ✅ Global Impact: Contribute to clinical studies and regulatory activities that shape the future of medicine.
- ✅ Growth Opportunities: Be part of a company that encourages learning and internal movement across roles.
- ✅ Inclusive Culture: Fortrea believes in diversity, equity, and inclusion, offering a respectful and empowering work environment.
📈 Who Should Apply?
These roles are ideal for:
- Recent graduates with at least 6 months of clinical experience.
- Young professionals looking to specialize in regulatory documentation or TMF management.
- MBA Pharma grads looking for hybrid roles that combine business and compliance.
- Anyone passionate about the behind-the-scenes roles that make medicines safer and more accessible.
📌 Application Reminder:
- TMF Associate I (Bangalore): Application closes May 12, 2025
- Regulatory Operations Assistant II (Pune): Application closes May 1, 2025
If you missed the second role’s deadline, keep an eye on upcoming positions from Fortrea, especially if you’re focused on regulatory affairs, TMF coordination, or documentation control.
🔚 Conclusion
In conclusion, whether you’re stepping into the industry or looking for that next leap in clinical documentation and regulatory affairs, Fortrea’s job openings offer purpose, growth, and a globally respected work environment. With roles in Bangalore and Pune, you can find your fit and contribute to shaping the future of healthcare.
Take the first step toward your pharma career with confidence — and make your mark with Fortrea.
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