SVP - Head of Regulatory Affairs
September 20
Description
• Lead regulatory strategy and operations for Orca Bio’s product pipeline. • Collaborate with teams to ensure regulatory alignment with business objectives. • Guide development and submission of regulatory documents. • Serve as the primary contact for regulatory agencies. • Prepare and participate in key regulatory meetings. • Facilitate communication with regulatory agencies for feedback. • Build, mentor, and lead the Regulatory Affairs team. • Foster a culture of compliance, accountability, and innovation. • Oversee development and submission of regulatory documentation. • Ensure compliance with global regulatory requirements. • Maintain regulatory affairs systems with record-keeping.
Requirements
• Minimum of 15+ years of U.S. regulatory affairs experience as a proven leader within the biotech / pharmaceutical industry, or as a seasoned regulator, with additional global experience preferred. • Advanced degree (PharmD, PhD, MD) in biology/life sciences/or related discipline preferred. • Notable track record of successful regulatory leadership, preferably with a breadth of experience across multiple therapeutic areas and disease states, including clinical stage Oncology biologics/cell therapy products. • Viewed as an expert in the field, with the ability to identify existing regulatory pathways as well as helping to create, define and implement novel regulatory pathways to registration. • Prior experience with successful filing of late-stage regulatory submissions (BLA preferred). • Prior experience working as head of regulatory in a small biotech environment with limited resources, including hands-on mindset, creative thinking and calculated risk taking. • The successful candidate must have strong regulatory knowledge of drug development, including clinical trial requirements, trial design and data analysis, CMC, manufacturing, quality, post-marketing surveillance, marketing and sales.
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