Department: Regulatory Affairs
◾ Senior Officer – Analytical Documents Reviewer (Analyst)
◾ Location: Akola, Maharashtra
◾ Employment Type: Full-Time
About Leben Life Sciences
Leben Life Sciences Pvt. Ltd. is a leading pharmaceutical formulation company with over four decades of excellence. Our EU-GMP-approved manufacturing facility at Akola specializes in Oral Solid Dosage (OSD) and Semi-Solid formulations for global markets.
We are looking for a motivated and detail-oriented professional to join our Regulatory Affairs (Formulation) team as a Senior Officer – Analytical Documents Reviewer (Analyst).
Key Responsibilities
◾ Prepare, review, and compile analytical sections of CTD/eCTD dossiers, including Specifications, AMV, and CoA.
◾ Review analytical method validation, method transfer, stability, and impurity data.
◾ Ensure compliance with ICH guidelines (Q2, Q3, Q6, Q8 & Q9).
◾ Coordinate with QC Analytical, ADL, R&D, and Stability teams.
◾ Perform gap assessments against regulatory requirements for target markets.
◾ Prepare responses to regulatory authority queries.
◾ Support internal and external audits with analytical documentation.
◾ Stay updated on analytical regulatory guidelines and documentation requirements.
Eligibility Criteria
◾ M.Sc./M.Pharm/B.Pharm in Pharmaceutical Analysis, Chemistry, or a related discipline.
◾ 2–3 years of hands-on HPLC experience (mandatory).
◾ Experience in QC or Analytical Development Laboratory (ADL).
◾ Knowledge of analytical method validation, stability studies, and pharmaceutical documentation.
◾ Good understanding of CTD/eCTD documentation and ICH guidelines.
◾ Strong analytical, documentation, and communication skills.
Why Join Us?
Work with a reputed pharmaceutical organization having over 40 years of industry experience.
Be part of an EU-GMP-approved manufacturing facility.
Opportunity to contribute to global regulatory submissions.
Collaborative work environment with excellent career growth opportunities.
◾ Apply Now
Email: [email protected]
Location: Akola, Maharashtra
Contact: +91 7498035480
Pay: ₹300,000.00 - ₹500,000.00 per year
Benefits:
- Flexible schedule
- Leave encashment
- Provident Fund
Work Location: In person
