Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada

Role: Senior Manager of Regulatory Affairs, focused on developing and executing US and Canada regulatory strategies for on-market and in-development pharmaceutical products across multiple therapeutic areas. Responsibilities include serving as a key liaison with health authorities (FDA), preparing and reviewing regulatory submissions, ensuring compliance with regional requirements, and supporting regulatory interactions and responses. The role also involves advising internal teams on regulatory issues, negotiating with agencies, and maintaining regulatory documentation in line with evolving guidelines. Qualifications: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or related field; at least 6 years in regulatory affairs or pharmaceutical R&D, with 2-3 years of direct regulatory experience; strong negotiation, communication, and cross-functional collaboration skills. Preferred: Advanced degrees or certifications, global regulatory experience, and experience interfacing with government agencies. The position requires working a hybrid schedule from locations in IL, NJ, or CA, with occasional travel. High-value specifics include focus on US and Canada markets, involvement in pharmaceutical regulatory processes, and experience in complex, matrixed environments.