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.

Team-oriented work environment with excellent career growth opportunities.

◾ Apply Now

Email: [email protected]

Location: Akola, Maharashtra

Contact: +91 (phone hidden)

Pay: ₹300,000.00 - ₹500,000.00 per year

Benefits:

- Flexible schedule
- Leave encashment
- Provident Fund

Work Location: In person

📌 Senior Officer Regulatory Affairs (Akola)
🏢 Leben Life Sciences
📍 Akola