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.

- Positive 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-XXXXXXXXXX

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📌 Senior Officer-Analytical Documents Reviewer (Analyst) (India)
🏢 Leben Life Sciences
📍 India