Manager, Regulatory Affairs Strategy

Role: Regulatory Affairs Manager supporting late-stage development and registration for rare disease therapies, primarily in global markets. Responsibilities: lead regulatory strategy implementation, coordinate preparation and submission of INDs, CTAs, marketing applications (NDA, BLA, MAA), and lifecycle activities; liaise with Health Authorities; collaborate with cross-functional teams (clinical, nonclinical, CMC, medical writing); manage regulatory timelines, risks, and external vendors; contribute to regulatory intelligence and process improvements. Requirements: Bachelor's in Life Sciences or related; 6+ years in pharmaceutical/biotech regulatory affairs; experience supporting clinical-stage programs, global submissions, and regulatory compliance; knowledge of FDA, EMA, ICH standards. Preferred: advanced degree (MS, PharmD, PhD); experience with Phase 3/late-stage development, post-approval changes, and global regulatory agencies; strong project management, communication, and cross-functional collaboration skills. HighValue: rare disease focus, global regulatory environment, late-stage and lifecycle management expertise, experience with IND/CTA and marketing applications, international travel (~10%). WorkSetup: remote based in San Diego with some domestic and international travel.