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Leben Life Sciences Pvt. Ltd. (LLS) is an established pharmaceutical formulation company with over four decades of expertise. LLS operates an EU-GMP Approved Global Standard OSD & Semi-solids Formulation Manufacturing Facility located at Akola (Maharashtra).
Position:
Sr. Officer – Regulatory Affairs (Technical Document Reviewer)
Department:
Regulatory Affairs (Formulation)
Key Responsibilities:
- Review and verify all technical documents including Analytical Documents, CDPs, and product quality-related 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 close gaps and finalize documents.
- Support in preparation and review of dossiers (CTD/eCTD/ACTD/ROW) and related regulatory submissions.
- Assist in lifecycle management of products – variations, renewals, and post-approval updates.
- Maintain regulatory documentation and support during audits/inspections.
Qualification & Skills:
- M. Pharm / B. Pharm
- 2–5 years’ experience in document review (Regulatory / AQA / R&D)
- Strong knowledge of ICH, EMA, USFDA, WHO guidelines
- Good analytical, communication, and coordination skills
How to Apply:
Interested candidates can share their resume via email:
📧 career@lebenlifesciences.com
📞 Contact: 7498035480
