Senior Director, Regulatory Affairs

A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.

Shuttle service from BART, CalTrain and the Ferry.

Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

Annexon Biosciences

is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported.

We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

Provides regulatory leadership in support of the development, registration, and life-cycle management of Annexon products by collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate, and implement global regulatory strategies and submissions, including CTAs, for new and ongoing clinical studies

Lead and manage all aspects of major global marketing applications, including BLAs, NDAs, and MAAs as applicable, working with internal cross-functional teams, external consultants, and vendors to drive successful submissions, regulatory review activities, and post-submission commitments

Provides strategic regulatory direction on programs to support the global regulatory plan, development plans/clinical study designs, risk assessments, critical issue management, and Health Authority interactions.

Proactively identifies regulatory risks and develops mitigation strategies to support program objectives

Lead regulatory planning for major milestones, including INDs, CTAs, Fast Track, Breakthrough Therapy, PRIME, Orphan Drug, etc.

Lead and manage interactions with FDA, EMA, and other global Health Authorities, including development of regulatory strategies, briefing documents, meeting preparation, meeting leadership, and regulatory correspondence