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ADMA Biologics

Regulatory Affairs Manager - Biopharma (Boca Raton)

northern, KY

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About this opportunity

ADMA Biologics lists this Regulatory Affairs Manager - Biopharma (Boca Raton) opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.

Job description

ADMA Biologics seeks a skilled Manager, Regulatory Affairs to lead regulatory submissions and strategy for Boca Raton operations. The role involves coordinating INDs, BLAs, CTD documents, and lifecycle submissions, while guiding cross-functional teams and liaising with FDA and other regulators.

The position requires extensive regulatory experience across drug development, strong communication abilities, and a thorough understanding of GMP, GCP, and documentation practices.

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