Sr. Manager, Regulatory CMC

BioMarin Pharmaceutical
San Rafael, CA
Category Operations
Job Description

BioMarin is seeking a Sr. Manager for Regulatory CMC to ensure successful global regulatory submissions and management of post-approval variations. The role involves planning, preparing regulatory documents, providing guidance to stakeholders, and proactive issue identification. They are seeking a leader to translate scientific expertise into pharmaceutical innovation.

Requirements

  • Planning, preparation, and submission of global regulatory CMC-related content.
  • Colla...

    Requirements: 7+ years of experience in Regulatory Affairs/CMC. Understanding of drug development regulations & marketing authorization procedures. GMP environment experience required