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.)
Position : Sr. Officer - Analytical Documents Reviewer (Analyst)
Department : Regulatory Affairs (Formulation)
Key Responsibilities :
• Prepare, review, and compile analytical sections of CTD/eCTD dossiers (Specifications, AMV, CoA).
• Review analytical method validation, method transfer, stability, and impurity data.
• Ensure analytical compliance with ICH Q2, Q3, Q6, Q8, and Q9.
• Coordinate with QC Analytical, ADL, R&D, and Stability teams.
• Perform gap assessment against target market regulatory requirements.
• Prepare analytical responses to regulatory authority queries.
• Support internal and external audits with analytical regulatory documentation.
• Track and communicate updates in analytical regulatory guidelines.
Eligibility Criteria :
• M.Sc. / M.Pharm / B.Pharm in Pharmaceutical Analysis, Chemistry, or related discipline.
• 2-3 years of hands-on HPLC experience is mandatory.
• Candidates with QC or ADL (Analytical Development Lab) background are eligible.
• Experience in analytical method validation, stability analysis, and documentation preferred.
• Good understanding of ICH guidelines and regulatory documentation.
Interested candidates can mail their resume on : career@lebenlifesciences.com
Last Date : 15th February 2026
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