Annexon Biosciences

Annexon Biosciences

Senior Director, Regulatory Affairs

San Francisco Bay Area · Director

Sponsorship not specified$216k-$241kDetected 5 days ago
Clinical TrialsPatient CareFDA RegulatoryLeadershipCommunicationCollaborationRegulatory Affairs

About the role

  • 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.

Responsibilities

  • The Senior Director, Regulatory Affairs will oversee the content and preparation of all regulatory documents and submissions related to applicable programs.
  • 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
  • Lead regulatory planning for major milestones, including INDs, CTAs, Fast Track, Breakthrough Therapy, PRIME, Orphan Drug, etc.
  • Manage day to day reports, submissions, requests for Annexon products
  • Recruit, mentor, develop, and manage regulatory professionals and consultants to ensure organizational excellence and successful execution of corporate objectives.
  • We believe that our differences enable us to be a better team - one that makes better decisions, drives innovation, and delivers better business results.
  • Proactively identifies regulatory risks and develops mitigation strategies to support program objectives

Requirements

  • Other duties as required.

Skills

  • PhD/PharmD with 12+ years' experience in Regulatory Affairs or BS/MS/MSN with 14+ years' experience.
  • Experience working directly with the FDA and EMA. In-depth knowledge of FDA and EMA regulations and CTD/eCTD requirement
  • Experience supporting development of biologics and/or small molecules, preferably in rare disease, immunology, and/or neuroscience,

Compensation

  • $216,000 - $241,000

Benefits

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

Company info

  • 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.
  • 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.
  • 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!
  • 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.
  • 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.
  • 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.

Equal opportunity

  • Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.
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