UMEDICA Laboratories - Manager - Regulatory Affairs

Description:

About 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 Responsibilities:

Regulatory 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:

- Coordinate controlled correspondences with the FDA.

- Support preparation of meeting requests, meeting packages, and documentation for FDA interactions.

Cross-functional Collaboration:

- Work closely with R&D, QA, QC, Formulation, and Manufacturing teams to ensure regulatory alignment throughout the development lifecycle.

- Provide regulatory input on product development, particularly for injectables and liquid dosage forms.

Documentation & Compliance:

- Ensure timely maintenance of submission records and regulatory databases.

- Monitor regulatory changes and communicate impacts to internal teams.

Qualifications & Experience:

- Around 12 years of experience in US Regulatory Affairs.

- Strong working knowledge of ANDA/NDA dossier requirements.

- Exposure to FDA interactions and controlled correspondences.

- Excellent communication, documentation, and cross-functional coordination skills