Global Regulatory Affairs Director - Inflammation and Rare Disease

Role: Global Regulatory Affairs Director focusing on Inflammation and Rare Diseases, leading regulatory strategy development, global registration, and lifecycle management of biopharma products. Responsibilities: lead and develop global regulatory strategies, direct Regulatory Teams (GRTs), serve as regulatory representative on product teams, oversee global filings (clinical trial applications, marketing authorizations, label extensions, CMC updates), and advise on regulatory pathways including expedited programs and orphan designation. Ensure compliance with worldwide regulations, communicate strategies across functions, and manage agency interactions and key regulatory meetings. Requirements: Doctorate with 4+ years, Master’s with 7+ years, or Bachelor's with 9+ years in biotech or science, with regulatory experience; strong leadership, communication, and strategic planning skills. Preferred: ability to build effective teams, understand scientific/clinical data, navigate global regulatory environments, and negotiate. HighValue: Regulatory leadership in biotech, global filings, orphan/expedited pathways, biologics or small molecules, late-stage development or post-approval, with cross-functional collaboration. Location: not specified, likely hybrid or remote; travel requirements not detailed.