Executive Director, Regulatory Affairs Liaison

Role: Senior regulatory leader responsible for defining and executing global regulatory strategies for ophthalmology programs within the General Medicine portfolio. Objectives include streamlining development timelines, obtaining approvals, and ensuring compliant labeling. Responsibilities: oversee global regulatory strategy development, manage and mentor a team of Global Regulatory Leads, review and approve regulatory submissions, key communications, and labeling, and represent the company in external regulatory engagements and internal governance. Requirements: B.S./M.S. with 12+ years in drug development (or MD/PhD/PharmD with 9+ years, including 7+ in regulatory affairs); proven success in NDA/BLA approvals and global regulatory expertise; strong leadership and communication skills. Preferred: experience in retinal disease, ophthalmology, and both small and large molecule programs; prior roles as Global Regulatory Lead, with extensive U.S. and international regulatory experience. High-Value: ophthalmology, retinal diseases, global regulatory strategy, NDA/BLA approvals, cross-functional leadership, 10% travel, hybrid work setup.