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Job Opening at Leben Life Sciences Pvt. Ltd. – Regulatory Affairs (Formulation)
Company: Leben Life Sciences Pvt. Ltd.
Location: Akola, Maharashtra
Department: Regulatory Affairs (Formulation)
Position: Sr. Officer – Technical Document Reviewer
About the Company
Leben Life Sciences Pvt. Ltd. (LLS) is a well-established pharmaceutical formulation company with over four decades of excellence in the industry. The company operates an EU-GMP approved global standard OSD & Semi-solids formulation manufacturing facility at Akola (M.S.), delivering high-quality healthcare solutions worldwide.
Key Responsibilities
- Review and verify technical documents including analytical documents, CDPs, and product quality documents.
- Ensure compliance, accuracy, and consistency across specifications, test methods, and reports.
- Cross-check analytical methods, COAs, validation reports, and related documentation.
- Coordinate with QA, QC, ADL, FDL, and Production teams to finalize documents.
- Support preparation and review of regulatory dossiers (CTD/eCTD/ACTD/ROW) and submissions.
- Assist in lifecycle management activities including variations, renewals, and post-approval updates.
- Maintain regulatory documentation and support audits/inspections.
🎓 Qualification & Skills
- Education: M.Pharm / B.Pharm
- Experience: 2–3 years in document review (Regulatory/AQA/R&D).
- Strong knowledge of ICH, EMA, USFDA, and WHO guidelines.
- Good analytical, communication, and coordination skills.
📩 How to Apply
Interested candidates can share their updated resume at:
📧 career@lebenlifesciences.com
📞 Contact: 7498035480
If you are a regulatory professional looking to grow your career in a reputed pharmaceutical organization, this is a great opportunity to join a dynamic and compliance-driven team.
