Director/Sr. Director, Regulatory Affairs (SSF, CA or Remote)
Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. 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.
Desired Candidate Profile
Annexon Biosciences seeks a Director/Sr Director, Regulatory Affairs to provide a critical leadership role in the planning and execution of the Company’s regulatory strategies and compliance requirements. This position will report to the Head of Regulatory and will work 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.
- Familiarity with eCTD technical requirements.
- Highly organized with proficiency accessing documentation utilizing multiple electronic systems.
- Excellent communication and interpersonal skills are essential.
- Residence in the bay area preferred.
- Annexon’s Director/Sr. Director, Regulatory Affairs will be required to be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws.
Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.