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. 

Responsibilities: 

•    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

Qualifications: 

•    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