Regulatory Affairs Associate

Assisting in the creation and submission of regulatory documents, the full-time remote Regulatory Affairs Senior Associate will support US regulatory activities, maintain regulatory documentation, and collaborate with cross-functional teams to ensure compliance with FDA submissions. Key responsibilities Support the US Regulatory Lead in the development and submission of IND, BLA, and NDA applications Maintain and archive regulatory documents and product regulatory history in the document management system Prepare supportive documentation for regulatory deliverables and coordinate responses to FDA inquiries Required qualifications Master's degree in a relevant field Bachelor's degree with 2 years of regulatory or pharmaceutical experience Associate's degree with 6 years of regulatory or pharmaceutical experience High school diploma/GED with 8 years of regulatory or pharmaceutical experience