Leben Life Sciences Pvt. Ltd. (LLS) is an established pharmaceutical formulation company for more than four decades. LLS has following openings for its EU-GMP Approved Global Standard OSD & Semi-solids Formulation manufacturing facility at Akola (M.S.)
Post : Sr. Officer - (Technical Document Reviewer)
Department : Regulatory Affairs (Formulation)
Key Responsibilities :
• Review and verify all technical documents including Analytical Documents, CDPs, 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 in audits/inspections.
• Prepare, compile, and review regulatory dossiers for submission.
• Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams.
• Co-ordinating with cross functional teams like R&D,QA/QC Production to collection of data for submission.
• Maintain regulatory files and track submission and approval status using internal systems.
• Provide regulatory input during product development, scale-up, and lifecycle management.
• Supporting the review of product labels, cartons, and inserts to ensure compliance with regulatory.
• Review and interpret regulatory guidelines and notify stakeholders of relevant updates.
Job Location : Akola
Qualification & Skills :
• M.Pharm / B.Pharm
• 2-3 years' experience in document review (Regulatory/AQA/R&D), strong knowledge of ICH, EMA, USFDA, WHO guidelines, and good analytical, communication, and coordination skills.
Interested candidates can mail their resume on : career@lebenlifesciences.com
Last Date : 15th March 2026
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