UMEDICA Laboratories - Manager - Regulatory Affairs

UMEDICA

UMEDICA Laboratories is a vertically integrated pharmaceutical company with strong global presence across 85+ countries.

With state-of-the-art, globally accredited manufacturing facilities (USFDA, EU, PIC / S), UMEDICA continues to grow through innovation, quality excellence, and regulatory expertise.

As part of our expansion, we are seeking a highly capable Manager Regulatory Affairs (US Markets) to support regulatory submissions and lifecycle management for the US market.

Key Submissions :

• Prepare and support end-to-end ANDA / NDA submissions to the USFDA.
• Assist in preparing query responses, amendments, annual reports, and post-approval submissions (PAS, CBE).
• Ensure all submissions comply with current USFDA regulations and guidance documents.

Regulatory Communication :

Documentation & Compliance :

Qualifications & Experience :

(ref : iimjobs.com)