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About the Company:
Leben Life Sciences Pvt. Ltd. (LLS) is an established pharmaceutical formulation company with over four decades of excellence. LLS operates a EU-GMP Approved Global Standard OSD & Semi-solids Formulation Manufacturing Facility located at Akola (Maharashtra).
🔹 Position 1: Sr. Officer – Regulatory Affairs (Technical Document Reviewer)
Department: Regulatory Affairs (Formulation)
Key Responsibilities:
- Review & verify technical documents (Analytical Documents, CDPs, product quality-related docs).
- Ensure compliance, accuracy & consistency across test methods, specifications, and reports.
- Cross-check COAs, validation reports & documentation.
- Coordinate with QA, QC, ADL, FDL & Production teams to finalize documents.
- Support dossier preparation & submission (CTD/eCTD/ACTD/ROW).
- Assist in lifecycle management (variations, renewals, post-approval updates).
- Maintain regulatory documentation, support in audits/inspections.
Qualification & Skills:
- B. Pharm / M. Pharm
- 2–5 Years’ experience in Regulatory / AQA / R&D document review
- Knowledge of ICH, EMA, USFDA, WHO guidelines
- Strong analytical, communication & coordination skills
🔹 Position 2: Officer / Sr. Officer – IPQA
Department: Quality Assurance
Qualification & Experience:
- B. Pharm / M. Pharm
- Minimum 3 Years’ experience in IPQA / QA
📍 Job Location: Akola, Maharashtra
📧 How to Apply:
Interested candidates can share their CV at career@lebenlifesciences.com
📞 Contact: 7498035480
