Senior Director, Regulatory Affairs
Annexon Biosciences
August 21, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Position: Senior Director, Regulatory Affairs
Responsibilities:
- Provide global regulatory leadership for development, registration, and life-cycle management of Annexon programs; act as Regulatory Lead for assigned programs.
- Develop and drive global regulatory strategies and plans; collaborate cross-functionally (Clinical Development/Operations, Medical Affairs, CMC, Quality) for CTAs and submissions for new and ongoing studies.
- Lead major global marketing applications (BLAs, NDAs, MAAs as applicable), coordinating internal teams, external consultants, and vendors for submissions, review activities, and post-submission commitments.
- Provide strategic regulatory direction on global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management, and Health Authority interactions; identify regulatory risks and develop mitigation strategies.
- Lead regulatory planning for major milestones (INDs, CTAs, Fast Track, Breakthrough Therapy, PRIME, Orphan Drug, etc.).
- Manage interactions with FDA, EMA, and other Health Authorities, including briefing documents, meeting preparation/leadership, and regulatory correspondence.
- Monitor and interpret evolving global regulatory requirements/guidance/trends; communicate implications to stakeholders.
- Manage day-to-day reports, submissions, and requests for products.
- Recruit, mentor, develop, and manage regulatory professionals and consultants.
Required Qualifications:
- PhD/PharmD with 12+ years in Regulatory Affairs, or BS/MS/MSN with 14+ years.
- Demonstrated experience leading BLA/NDA/MAA submissions with regulatory strategy, execution, and review activities.
- Ability to influence senior leaders and cross-functional stakeholders with strategic guidance and proactive risk assessment/mitigation.
- Experience working directly with FDA and EMA; in-depth knowledge of FDA/EMA regulations and CTD/eCTD requirements.
- Excellent regulatory writing/review skills; author/oversee high-quality submissions and Health Authority communications.
- Understanding of biotech/pharmaceutical regulatory environment and best practices.
- Proactive, creative, forward-thinking; integrated global strategy for regulatory/reimbursement/patient care.
- Experience in biologics and/or small molecules (preferably rare disease, immunology, and/or neuroscience).
- Leadership skills; experience interacting with vendors and partner companies.
Benefits:
- Flexible work schedules; remote opportunities; work-life balance.
- Shuttle service from BART, CalTrain and the Ferry.
- Competitive base salary and equity; employee stock purchase plan.
- Comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans) and other benefits.
Responsibilities:
- Provide global regulatory leadership for development, registration, and life-cycle management of Annexon programs; act as Regulatory Lead for assigned programs.
- Develop and drive global regulatory strategies and plans; collaborate cross-functionally (Clinical Development/Operations, Medical Affairs, CMC, Quality) for CTAs and submissions for new and ongoing studies.
- Lead major global marketing applications (BLAs, NDAs, MAAs as applicable), coordinating internal teams, external consultants, and vendors for submissions, review activities, and post-submission commitments.
- Provide strategic regulatory direction on global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management, and Health Authority interactions; identify regulatory risks and develop mitigation strategies.
- Lead regulatory planning for major milestones (INDs, CTAs, Fast Track, Breakthrough Therapy, PRIME, Orphan Drug, etc.).
- Manage interactions with FDA, EMA, and other Health Authorities, including briefing documents, meeting preparation/leadership, and regulatory correspondence.
- Monitor and interpret evolving global regulatory requirements/guidance/trends; communicate implications to stakeholders.
- Manage day-to-day reports, submissions, and requests for products.
- Recruit, mentor, develop, and manage regulatory professionals and consultants.
Required Qualifications:
- PhD/PharmD with 12+ years in Regulatory Affairs, or BS/MS/MSN with 14+ years.
- Demonstrated experience leading BLA/NDA/MAA submissions with regulatory strategy, execution, and review activities.
- Ability to influence senior leaders and cross-functional stakeholders with strategic guidance and proactive risk assessment/mitigation.
- Experience working directly with FDA and EMA; in-depth knowledge of FDA/EMA regulations and CTD/eCTD requirements.
- Excellent regulatory writing/review skills; author/oversee high-quality submissions and Health Authority communications.
- Understanding of biotech/pharmaceutical regulatory environment and best practices.
- Proactive, creative, forward-thinking; integrated global strategy for regulatory/reimbursement/patient care.
- Experience in biologics and/or small molecules (preferably rare disease, immunology, and/or neuroscience).
- Leadership skills; experience interacting with vendors and partner companies.
Benefits:
- Flexible work schedules; remote opportunities; work-life balance.
- Shuttle service from BART, CalTrain and the Ferry.
- Competitive base salary and equity; employee stock purchase plan.
- Comprehensive health benefits (medical, dental, vision, 401(k), flexible spending plans) and other benefits.