Senior Manager, Global Regulatory Strategy

Role: Senior Manager, Global Regulatory Strategy, leading regulatory activities for early-stage oncology and rare disease assets, supporting global submissions from IND/CTA to registration. Responsibilities: develop and execute global regulatory plans, prepare and manage IND/CTA submissions, liaise with health authorities (FDA, EMA, TGA, PMDA), support cross-functional teams (QA, Clinical, Research), and oversee compliance and risk mitigation. Requirements: Bachelor's in Life Sciences, Pharmacy, or related; 8+ years in Regulatory Affairs with substantial early-stage (IND/CTA) experience; strong knowledge of global regulatory frameworks, ICH guidelines, CTD/eCTD submissions, and health authority interactions. Preferred: advanced degree. HighValue: oncology, radiopharmaceuticals, early clinical development, global health authority engagement, regulatory lifecycle management. Work Setup: hybrid/remotely, with international stakeholder collaboration.