Senior Officer – Analytical Documents Reviewer (Analyst)
- Location: Akola, Maharashtra
- Department: Regulatory Affairs (Formulation)
- 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.
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.
� Email: [email protected]
� Location: Akola, Maharashtra
� Contact: +91 7498035480
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