Leben Life Sciences Hiring 2026: Senior Officer Opportunity in Regulatory Affairs

Leben Life Sciences Pvt. Ltd. (LLS), an established pharmaceutical leader for over 40 years, is currently seeking a specialized professional for its EU-GMP approved manufacturing facility in Akola, Maharashtra. This role is ideal for candidates with a strong analytical background looking to transition into or grow within Regulatory Affairs (Formulation).

Job Profile: Sr. Officer – Analytical Documents Reviewer

This position acts as a critical bridge between the laboratory and regulatory submissions, ensuring all analytical data meets global quality standards.

Key Responsibilities:

Dossier Compilation: Prepare and review analytical sections of CTD/eCTD dossiers, including Specifications, Analytical Method Validation (AMV), and Certificates of Analysis (CoA).
Data Review: Critically evaluate analytical method validation, method transfer, stability studies, and impurity profiles.
Compliance: Maintain strict adherence to ICH guidelines (specifically Q2, Q3, Q6, Q8, and Q9).
Cross-Functional Liaison: Coordinate with Quality Control (QC), Analytical Development (ADL), R&D, and Stability departments.
Regulatory Intelligence: Perform gap assessments against target market requirements and draft responses to queries from regulatory authorities.
Audit Support: Provide documentation support for both internal and external (regulatory) audits.

Eligibility Criteria

Education: M.Sc. / M.Pharm / B.Pharm in Pharmaceutical Analysis, Chemistry, or a related discipline.
Experience: * 2-3 years of mandatory hands-on experience with HPLC.
- Candidates currently working in QC or ADL (Analytical Development Lab) are highly encouraged to apply.
Technical Skills: Deep understanding of stability analysis, method validation, and regulatory documentation.