At Leben Life Sciences, we are committed to Providing Healthcare Responsibly by delivering quality, safe, and effective medicines to patients across India and global markets. With our EU-GMP & WHO-GMP certified manufacturing facility, advanced R&D; capabilities, and robust presence in domestic and international markets, we continue to build a team of passionate professionals.

Senior

Officer – Regulatory Affairs (Technical Document Reviewer)

? Experience: 3–5 Years

? Qualification: B.Pharm / M.Pharm

Key Responsibilities

✔ Review and verify analytical and technical documents, including CDPs, COAs, validation reports, specifications, and test methods.

✔ Ensure documentation complies with ICH, USFDA, EMA, WHO, and other applicable regulatory guidelines.

✔ Review and support the preparation of CTD/eCTD/ACTD dossiers and regulatory submissions.

✔ Coordinate with QA, QC, ADL, FDL, and Production teams to finalize technical documentation.

✔ Support product lifecycle management, including variations, renewals, and post-approval changes.

✔ Maintain regulatory documentation and assist during audits and inspections.

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