💼 Job Opportunity: Regulatory Affairs Executive/Sr. Executive – Shilpa Medicare Ltd.
📍 Location: Nacharam, Hyderabad
👨🔬 Position: Executive / Sr. Executive – Regulatory Affairs (Formulation)
🧑💼 Experience: 3–6 Years
🎓 Education: B.Pharm / M.Pharm
📝 Key Responsibilities:
📦 Manage pre/post-approval regulatory submissions for US / EU / Canada markets
📄 Review development documents & compile dossiers (eCTD publishing)
🧾 Handle CMC documentation, supplements, and annual reports
💉 Prepare Sterility Assurance Packages (injectables) & Pre-IND packages
✅ Respond to regulatory deficiencies, QMS approvals & packaging/labeling needs
🤝 Support cross-functional teams with compliance updates
💡 Preferred Experience:
💊 Experience in solid orals/injectables
📚 Familiarity with pharmacopoeia standards & QbD concepts
📬 How to Apply:
📧 Send your updated CV to: karthik.kumar@vbshilpa.com
📢 Note: Ideal for candidates with a strong background in regulatory documentation & pharmaceutical submissions.
🔄 Share with your network – someone in your circle might be the perfect fit!
