Senior Director, Regulatory Affairs

About this role

Company:

At Annexon Biosciences we are 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. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture!

Position:

This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio. The Senior Director serves as the Regulatory Lead for assigned programs and is a key strategic advisor to executive leadership on regulatory risks, opportunities, and health authority engagement strategies.

Responsibilities include developing and driving regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with regulatory agencies to support development and registration strategies. The Senior Director, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs.

Responsibilities include:

• 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,…