Manager, Regulatory Affairs Strategy

Role: Regulatory Affairs Manager supporting late-stage development and registration of therapies for rare diseases. Responsibilities include implementing global regulatory strategies, preparing and submitting applications (INDs, CTAs, NDAs, BLAs), leading regulatory documentation efforts, managing interactions with health authorities, and supporting lifecycle activities like post-approval changes. The role collaborates closely with Clinical, Nonclinical, CMC, Medical Writing, and Project teams, ensuring timely regulatory deliverables and compliance. Qualifications: Bachelor's in Life Sciences with 6+ years in pharmaceutical/biotech regulatory affairs, experience supporting clinical-stage programs, and knowledge of FDA, EMA, ICH requirements. Preferred: advanced degrees (MS, PharmD, PhD), experience with Phase 3 and late-stage development, and global post-approval activities. High-value specifics: focus on rare disease therapies, late-stage regulatory processes, global submissions, and health authority interactions. Work setup: primarily remote in San Diego with up to 10% domestic and international travel.