Regulatory Affairs Executive (API) – Research Scientist

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Looking to advance your career in Regulatory Affairs (API)? Fresenius Kabi Oncology Ltd. is hiring a Regulatory Affairs Executive (API) – Research Scientist for its Gurgaon facility. If you have experience in API regulatory documentation, analytical review, and global regulatory compliance, this is an excellent opportunity to join a leading global healthcare organization.

🔹 Key Responsibilities

✅ Evaluate impurities, specifications, and quality-related data
✅ Review API R&D and analytical documentation
✅ Prepare, review, and manage Drug Master Files (DMFs)
✅ Ensure compliance with ICH, USFDA, and other global regulatory guidelines
✅ Collaborate with cross-functional teams to support regulatory submissions and compliance activities

🎓 Requirements

✔️ Degree in Pharmacy, Chemistry, or Life Sciences
✔️ Good knowledge of ICH, USFDA, and global regulatory guidelines
✔️ Experience in API analytical development and R&D documentation
✔️ Strong analytical, communication, and presentation skills
✔️ Familiarity with analytical techniques, method development, validation processes, and regulatory affairs requirements
✔️ Ability to independently manage regulatory projects and documentation

🌟 Why Join Fresenius Kabi?

✅ Work with a globally recognized healthcare organization
✅ Collaborative and innovation-driven work environment
✅ Excellent learning and career growth opportunities
✅ Contribute to improving patient care through oncology research and regulatory excellence

If you’re passionate about API Regulatory Affairs, Drug Master Files (DMF), Analytical Development, and Global Regulatory Compliance, this is your chance to build a rewarding career with Fresenius Kabi Oncology Ltd.

📢 Follow FYND Talent Solutions for the latest Pharma, Regulatory Affairs, R&D, QA, QC, Manufacturing, Clinical Research, and Life Sciences job opportunities across India.

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