Executive Director, Regulatory Affairs

The role

This role provides global regulatory leadership to support the development, registration, and life-cycle management of innovative programs. The Executive Director serves as the Regulatory Lead for assigned programs and a senior strategic advisor to executive leadership.

What you will do

• Provide senior-level regulatory leadership for product development, registration, and life-cycle management
• Collaborate cross-functionally to develop and implement global regulatory strategies and submissions
• Lead and manage major global marketing applications including BLAs, NDAs, and MAAs
• Provide strategic regulatory direction for global regulatory plans and clinical study designs
• Proactively identify regulatory risks and develop mitigation strategies
• Lead regulatory planning for major milestones such as INDs, CTAs, Fast Track, Breakthrough Therapy, PRIME, and Orphan Drug
• Lead high-level interactions with FDA, EMA, and other global Health Authorities
• Monitor and interpret evolving global regulatory requirements and industry trends
• Manage day to day reports, submissions, and requests for Annexon products
• Build, mentor, develop, and lead regulatory professionals and consultants

Required qualifications

• PhD/PharmD with 15+ years’ experience in Regulatory Affairs or BS/MS/MSN with 17+ years’ experience
• Demonstrated experience leading major marketing application submissions (e.g., BLA, NDA, and/or MAA)
• Proven ability to advise and influence executive leadership and cross-functional stakeholders
• Experience working directly with the FDA and EMA
• In-depth knowledge of FDA and EMA regulations and CTD/eCTD requirement
• Excellent regulatory writing and review skills
• Understanding of the regulatory environment for biotech companies and pharmaceutical industry best practices
• Proactive, creative, forward-thinker with ability to think innovatively about integrated global strategy
• Demonstrated organizational leadership skills and ability to collaborate with outside vendors and partner companies

Nice to have

• Experience supporting development of biologics and/or small molecules, preferably in rare disease, immunology, and/or neuroscience

Benefits

• Flexible work schedules
• Remote opportunities
• Shuttle service from BART, CalTrain and the Ferry
• Competitive base salary
• Equity participation
• Employee stock purchase plan
• Medical
• Dental
• Vision
• 401(k)
• Flexible spending plans

About the company

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for neuroinflammatory diseases. The company is headquartered in Brisbane, CA.