💼 Entry Level Openings in Regulatory Affairs (CMC) | Syneos Health | Remote / Gurugram | 6 Months–1.5 Years Exp
🏢 Company: Syneos Health📍 Location: Remote (India) / Gurugram (Hybrid)
🎓 Eligibility: M.Pharm / M.Sc. / Masters in Life Sciences
🧪 Experience: 6 Months – 1.5 Years
💼 Position: Regulatory Associate / Sr. Regulatory Associate (Module 3, CMC)
📝 Job Type: Regulatory Affairs | CMC | Full-Time
🔎 Verified: ✅ Verified Job via Medical Jobs India – hitechplus.in
📄 Job Overview
Syneos Health, a leading global biopharmaceutical solutions organization, is hiring for Regulatory Associate / Senior Regulatory Associate (Module 3, CMC). This entry-level position focuses on regulatory submissions, lifecycle management, and ensuring compliance with global CMC standards. The role supports hybrid and remote work options from India.
🔬 Key Responsibilities
- ✔ Prepare and review Module 3 sections for post-approval CMC variations, renewals, and annual reports.
- ✔ Contribute to IND, NDA, and lifecycle submission components.
- ✔ Work with regulatory information systems like Veeva RIMs and Trackwise.
- ✔ Conduct quality checks for data accuracy and regulatory compliance.
- ✔ Maintain project-specific documentation and regulatory databases.
- ✔ Collaborate with internal and client teams on submission deliverables.
- ✔ Identify potential risks and propose mitigation strategies.
✅ Eligibility & Skills Required
- 🎓 M.Pharm / M.Sc. in Life Sciences or equivalent.
- 🧩 6 months – 1.5 years of experience in Regulatory Affairs (CMC preferred).
- 💻 Proficiency in Microsoft Office; familiarity with Veeva RIMs or Trackwise is a plus.
- 🗣 Strong communication and analytical skills.
- ⚡ Ability to manage multiple projects independently.
- 🌐 Fluency in English (written and verbal).
🎁 Why Join Syneos Health?
- 🌍 Work with a global leader supporting 94% of FDA-approved novel drugs in the last 5 years.
- 📈 Excellent career development and continuous learning programs.
- 💼 Hybrid/Remote flexibility with global project exposure.
- 🤝 Collaborative team culture and mentorship opportunities.
- 🏆 Recognition and reward programs for top performers.
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🟢 Verified Job via Medical Jobs India – hitechplus.in
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