Regulatory Lead

Role: Senior Regulatory Affairs leader overseeing global filings and compliance for a late-stage ophthalmic biologic product with FDA approval and European marketing authorization. Responsibilities: manage end-to-end preparation and submission of BLA, MAA, INDs, CTAs, and post-approval lifecycle activities; serve as primary interface with FDA, EMA, MHRA; develop regulatory strategies for biologics and combination devices; lead interactions with health authorities and manage cross-functional teams and vendors; ensure regulatory compliance for labeling and promotional materials. Requirements: Bachelor's in life sciences; 8+ years in regulatory affairs within biopharma, with experience in biologics, combination products, and global filings; proven track record with FDA and European authorities; strong CMC and manufacturing documentation expertise; willingness to work US/EU hours. Preferred: ophthalmology/retina experience; experience supporting product launches or international expansion; background managing consultants and cross-company teams; mentoring experience. High-value specifics: biologics, combination devices, FDA/EMA/UK MHRA engagement, global regulatory strategy, product lifecycle management, remote work (US-based, East Coast preferred).