Annexon Biosciences
Vice President, Regulatory Affairs
Annexon Biosciences, San Francisco, California, United States, 94199
Overview
Vice President, Regulatory Affairs
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today. 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-Barr 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. This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative and novel programs within the Annexon portfolio. Responsibilities include developing regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with global regulatory agencies to support development and registration strategies. The Vice President, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs. Additionally, this individual will mentor junior members of the regulatory team and anticipate and plan for changes in FDA and EU regulations and requirements.
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Vice President, Regulatory Affairs
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today. 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-Barr 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. This role provides global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative and novel programs within the Annexon portfolio. Responsibilities include developing regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with global regulatory agencies to support development and registration strategies. The Vice President, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs. Additionally, this individual will mentor junior members of the regulatory team and anticipate and plan for changes in FDA and EU regulations and requirements.
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