If you’re a professional with a strong foundation in life sciences or pharmacy and looking to transition into high-paying roles in medical writing or regulatory operations, this is your chance! Fortrea, a globally recognized pharmaceutical and clinical research organization, is offering career-changing roles in Mumbai and Pune.
Whether your strength lies in clinical documentation or regulatory submissions, Fortrea provides an excellent platform to work on impactful projects, gain global exposure, and grow in a challenging yet rewarding environment.
💼 Job Opportunities Overview
1️⃣ Medical Writer II – Mumbai
Experience Required: 3–5 years
Location: Mumbai (Hybrid)
Salary Range: ₹8–15 LPA
Education: Master’s or Ph.D. in Life Sciences, Pharmacy, Medicine, or a related discipline
2️⃣ Senior Regulatory Operations Specialist I – Pune
Experience Required: 4–7 years
Location: Pune (Hybrid)
Salary Range: ₹10–18 LPA
Education: B.Pharm/M.Pharm, MSc in Pharma Sciences, Regulatory Affairs
🧾 Key Responsibilities
📘 Medical Writer II – Mumbai
As a Medical Writer II, you’ll be at the forefront of clinical communication and regulatory documentation. Your primary duties will include:
- ✍️ Drafting clinical study protocols, CSRs (Clinical Study Reports), and patient safety narratives
- 🧠 Interpreting pharmacokinetics, pharmacodynamics, and statistical data
- 📊 Contributing to scientific publications (abstracts, posters, manuscripts)
- 📂 Overseeing CSR appendices compilation
- 🕒 Ensuring timely delivery and maintaining document quality standards
- 👥 Mentoring junior writers and supporting cross-functional teams
- 🤝 Maintaining strong relationships with internal teams and external sponsors
📄 Senior Regulatory Operations Specialist I – Pune
As a Regulatory Operations Specialist, your responsibilities will involve:
- 🧪 Preparing, compiling, and reviewing CMC documents for global submissions (ANDAs, NDAs, DMFs)
- 📁 Managing change control, OOS/OOT investigations
- 🧫 Supporting global labeling, stability data review, and API dossier development
- 🔬 Conducting literature surveys for regulatory intelligence
- 💻 Performing CSV (Computerized System Validation) activities and document upgrades
- ✔️ Ensuring regulatory compliance with USFDA, EMA, WHO, and other standards
📌 Essential Skills Required
Whether you’re in writing or regulatory ops, success at Fortrea demands a combination of technical and soft skills.
✅ Medical Writer II:
- Strong command of scientific writing and clinical documentation
- Knowledge of ICH-GCP guidelines, research protocols, and biostatistics
- Hands-on experience with document management systems and MS Office
- Ability to interpret complex scientific data and convert it into clear, accurate documents
✅ Regulatory Operations Specialist:
- Deep understanding of global regulatory compliance, GMP practices, and dossier preparation
- Familiarity with regulatory databases and e-submission platforms
- Proficiency in evaluating CMC data, labeling, and validation reports
- Ability to manage timelines, audits, and interdepartmental coordination
🌍 About Fortrea
Fortrea is not just another clinical research company. It’s a global innovation hub that supports the pharma industry through a wide range of services—from early drug development to post-market compliance. With a reputation built on scientific integrity, operational excellence, and regulatory know-how, Fortrea empowers professionals with meaningful work and global exposure.
At Fortrea, your contributions are valued, recognized, and rewarded—making it one of the top employers in the pharma clinical space.
💡 Why Join Fortrea?
Here’s why professionals are choosing Fortrea for their career growth:
✅ Hybrid work flexibility (perfect for balancing work and personal life)
✅ Access to cutting-edge drug development platforms
✅ A culture of mentorship, upskilling, and diversity
✅ Opportunity to contribute to life-saving therapies and research
✅ Attractive salary packages aligned with industry benchmarks
🎓 Who Should Apply?
This opportunity is ideal for candidates who:
✔ Have prior experience in clinical writing or regulatory submissions
✔ Hold a relevant degree like B.Pharm, M.Pharm, MSc, or PhD
✔ Are familiar with the regulatory landscape across India, US, and EU
✔ Are looking for career stability and advancement in clinical domains
✔ Thrive in a research-driven, deadline-oriented work culture
📅 Important Application Dates
- 🗓 Medical Writer II – Apply before May 16, 2025
- 🗓 Regulatory Operations Specialist – Apply before May 10, 2025
Pro tip: Polish your resume to reflect relevant experience, highlight certifications (if any), and showcase your key writing or regulatory projects.
🧭 Career Path & Growth
Fortrea encourages professional growth through internal mobility, leadership training, and specialized certifications. Depending on your performance and interest, you can move into:
- ➡️ Medical Writing Lead
- ➡️ Global Regulatory Strategy Head
- ➡️ Submission Manager
- ➡️ Scientific Affairs Specialist
- ➡️ Quality Review & Auditing Roles
Whether you’re looking for scientific depth or regulatory breadth, Fortrea’s ecosystem supports long-term success.
📝 Final Thoughts
If you’re ready to take your clinical documentation or regulatory expertise to the next level, Fortrea’s current openings in Mumbai and Pune are golden opportunities. These high-paying, hybrid roles are more than just jobs—they’re platforms to influence real-world drug development and patient safety.
Step into a future-focused organization that values scientific excellence, regulatory discipline, and professional growth. Your next big move in the pharma world starts here—don’t miss it.
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