Regulatory Affairs Associate

Supporting regulatory activities remotely, the full-time Senior Associate - Regulatory Affairs will assist in the creation and submission of regulatory documents, maintain product regulatory history, and ensure compliance with submissions to regulatory agencies. Key responsibilities Assist U.S. Regulatory Lead with IND/BLA documentation and maintain regulatory history documents Review regional components of the Global Regulatory Plan and coordinate collection of functional documents for regulatory applications Prepare regulatory packages and provide regulatory support to Commercial, Medical, and Clinical departments through cross-functional interactions Required qualifications Master's degree or Bachelor's degree with 2 years of Regulatory Affairs experience Associate's degree with 6 years of Regulatory Affairs experience or High school diploma/GED with 8 years of experience Experience in regulated industry, science, or clinical practice Strong organizational skills Ability to manage timelines effectively