Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada

Role: Senior Manager of Regulatory Affairs for US & Canada, responsible for developing and executing regulatory strategies for on-market and in-development products within specified therapeutic areas. Responsibilities include liaising with health authorities (FDA), preparing and reviewing regulatory submissions, ensuring compliance with US and Canada regulations, and supporting approval processes. The role involves cross-functional collaboration with Clinical Development, Public Affairs, Legal, and Commercial teams, along with providing regulatory guidance and decision-making. It also includes negotiation with regulatory agencies and maintaining submission timelines. Qualifications: Bachelor's degree in pharmacy, biology, chemistry, pharmacology or related field; minimum 6 years of regulatory affairs or pharmaceutical industry experience, including 2–3 years of direct regulatory activities; demonstrated negotiation and communication skills; experience in complex, matrix environments; global regulatory experience a plus. High-value: Focus on pharmaceutical regulatory strategy for products in multiple therapeutic areas, including immunology, oncology, and neuroscience; involvement with US and Canada health authorities; experience with regulatory submissions, responses, and health authority meetings; hybrid work setup from Illinois, New Jersey, or California with some travel.