Senior Director, Regulatory Affairs

Responsibilities

• Provide global regulatory leadership for the development, registration, and life-cycle management of Annexon products
• Lead and manage major global marketing applications including BLAs, NDAs, and MAAs
• Develop and implement global regulatory strategies and detailed plans to meet company objectives
• Manage interactions with FDA, EMA, and other global Health Authorities
• Lead regulatory planning for major milestones such as INDs, CTAs, Fast Track, and Orphan Drug designations
• Proactively identify regulatory risks and develop mitigation strategies
• Recruit, mentor, and manage regulatory professionals and consultants
• Monitor and interpret evolving global regulatory requirements and industry trends

Requirements

• PhD/PharmD with 12+ years of experience in Regulatory Affairs or BS/MS/MSN with 14+ years of experience
• Demonstrated experience leading major marketing application submissions (BLA, NDA, MAA)
• Direct experience working with the FDA and EMA
• In-depth knowledge of FDA/EMA regulations and CTD/eCTD requirements
• Experience supporting the development of biologics and/or small molecules
• Proven ability to influence senior leadership and cross-functional stakeholders
• Strong regulatory writing and review skills

Preferred Qualifications

• Experience in rare disease, immunology, or neuroscience

Benefits

• Flexible work schedules and remote opportunities
• Competitive base salary and equity participation
• Employee stock purchase plan
• Comprehensive health benefits including medical, dental, and vision
• 401(k) and flexible spending plans
• Shuttle service from BART, CalTrain, and the Ferry

About the Company

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye.