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Trainee – Regulatory Affairs

Trainee Regulatory Affairs at Leben Life sciences

Leben Life Sciences Pvt. Ltd. (LLS), a reputed pharmaceutical formulation company with over four decades of excellence, is conducting a Walk-In Interview for the position of Regulatory Affairs Trainee at their EU-GMP Approved Global Standard Formulation Manufacturing Facility in Akola, Maharashtra.

This is a great opportunity for fresh M.Pharm graduates looking to kickstart their career in Regulatory Affairs with a reputed organization.

About the Leben Lifesciences

Leben Life Sciences is known for its robust regulatory standards and global quality manufacturing. With decades of industry presence and innovation, LLS offers a strong platform for learning and growth in the pharmaceutical regulatory domain.

Responsibilities of Trainee Regulatory Affairs

  • Prepared dossiers in CTD, ACTD, and country-specific formats for various countries.
  • Assessed required documents such as COA, PV, PDR, AMV, MFR, BMR, BPR and Stability data.
  • Prepared SmPC and reviewed Primary & Secondary packaging and Patient Information Leaflets.
  • Handled various regulatory authority & client’s queries and ensured timely submissions.
  • Coordinated with QA, QC, R&D and Production teams for regulatory documents and sample submissions.
  • Prepared various documents like FP Spec’s, FP COA and Stability data required for dossier preparation.

Related Job: Trainee Intern Regulatory Affairs at Genedrift

Walk-in Interview Schedule

Date: 07th May 2025 (Wednesday)
Time: 09:30 AM to 10:30 AM
Venue:
Leben Life Sciences Pvt. Ltd.
Plot No. C-20/1 & C-21, Phase III,
MIDC, Akola, Shivar, Maharashtra

Important Instructions for Walk In Interview

Candidates must carry hard copies of the following:

  • Updated CV
  • Color passport-size photo

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