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Executive Director, Regulatory Affairs Liaison

Scorpion Therapeutics

Executive Director, Regulatory Affairs Liaison (Global Regulatory Strategy) Key Responsibilities Oversee development and implementation of global regulatory strategy for ophthalmology/retinal disease programs for multiple indications to minimize time to approval and optimize labeling. Provide oversight to direct reports; serve as single global point of accountability for assigned projects; partner with international regulatory colleagues and engage global health authorities. Oversee strategy, review and approval of key regulatory deliverables: submissions, external communications, background packages, local registration study protocols, and labeling. Lead, manage, and review direct report performance, including regulatory strategy, resource allocation, and staff development. Represent the company at external initiatives, regulatory authority meetings, and internal committees. Provide strategic input into regulatory due diligence for licensing candidate review. Minimum Education B.S./M.S. (biological science or related); 12+ years relevant drug development experience (majority in regulatory). OR M.D./Ph.D./PharmD; 9+ years relevant drug development experience (at least 7 years in regulatory). Required Skills/Experience Independent delivery aligned with leadership; scientific knowledge; effective communication; worldwide regulatory agency familiarity. Success securing original NDA/BLA approvals. Strong interpersonal/negotiation skills; leadership experience building high-performing teams. Preferred Retinal disease/ophthalmology regulatory experience; people management. Experience across small/large molecule programs. Extensive U.S./international regulatory experience; prior Global Regulatory Lead experience. Additional Travel: 10%; Geographical scope: U.S. and global regulatory responsibility. Benefits: medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days; annual bonus and long-term incentive (if applicable). #J-18808-Ljbffr Scorpion Therapeutics

Vacancy posted 4 days ago
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