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Annexon Biosciences seeks a Senior Director/Director, Global Regulatory Affairs to provide a critical leadership role in the planning and execution of the Company’s regulatory strategies and compliance requirements. The position entails working in a highly collaborative environment with team members in Clinical Development, Clinical Operations, CMC, Biostatistics, Nonclinical, Clinical Pharmacology, Program Management, and Research.
Plan content and timelines of regulatory submissions to ensure alignment with agreed strategies
Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
Lead efforts for coordinating content and publishing documents for INDs, BLAs, and their associated maintenance
Work with department management on plans for IND/BLA submissions and lead their preparation
Take the lead role in preparation for project documents for Regulatory Agency meetings
Lead multidisciplinary efforts to produce regulatory documents including Investigator Brochures, Annual Reports and DSURs, Orphan Drug Applications, and Background Documents for Regulatory Authority meetings
Work with ex-US regulatory organizations to prepare applications, respond to queries, and maintain clinical activities outside of the United States
Maintain knowledge of the current regulatory environment, and interpret and communicate relevant issues
Assure compliance with regulatory standards and guidance documents
Prepare, submit, track, index, and archive electronic submissions
Provide Regulatory guidance to Development and Research teams
Liaise with external CRO Medical Writing and Regulatory Operations functions for coordinating and publishing submission documents
Other tasks and responsibilities as directed by the SVP, Global Regulatory Affairs and Quality Assurance
B.S./M.S. degree in a relevant discipline
Minimum of 8 years of pharmaceutical Regulatory Affairs experience
Thorough knowledge of the drug development process, drug laws, and global regulations and requirements is required
Experience supporting development stage programs (Phase 1-3); Experience in neurodegenerative disease research highly desirable
Strong analytical skills, problem solving ability, and presentation skills are required
Familiarity with eCTD technical requirements
Highly organized with proficiency accessing documentation utilizing multiple electronic systems
Excellent communication and interpersonal skills are essential
Internal Number: 0603-1
About Annexon Biosciences
Annexon Biosciences is a private, clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.