Reporting to the Chief Medical Officer (CMO), the Vice President of Regulatory Affairs will be responsible for developing and leading all regulatory strategies and activities and Quality Assurance for Angion Biomedica, including all regulatory submissions. This includes ensuring that all Angion’s regulatory goals are met, and in compliance with all current industry standards globally. This role will manage internal Regulatory and Quality staff, oversee third party Regulatory service providers, and will be a key member of the development leadership team. This position will be based out of the Boston MA office.
Contribute to the development and implementation of pre-clinical, clinical, CMC, regulatory strategy for projects in all stages of development (pre-IND through NDA)
Works cross-functionally with internal departments, including clinical, manufacturing, and third parties on Regulatory Affairs and Quality related issues.
Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities.
Defines strategies for, coordinate the execution of, and ensure the proper archival of regulatory submissions including clinical trial applications; Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Approvals (MAAs)
Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities, including meeting requests, briefing packages, and fast track applications.
Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents.
Present operational plans, scientific data and strategy to internal and external audiences, including regulators, key opinion leaders, partners, and executives.
Support post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials.
Responsible for cost-effective management of Regulatory Affairs department budget.
Maintain, create relevant SOPs, Work Instructions and other necessary guidance.
PhD with focus in Pharmaceutical Sciences or a technical field preferred. Will consider minimum MS degree holders:
15+(MS), 10+(PhD) years of relevant and current work experience in the fields of Regulatory Affairs, Product Development, and/or Clinical Operations.
5+ years of demonstrated success in regulatory team leadership role and proven management by influence.
Solid understanding of dossier requirements New Drug Application (NDA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD, CTA).
Ability to interpret, communicate, and present regulatory information in a clear and concise manner.
Strong written and oral communication skills.
For employment inquiries please contact Joanne Bazilio-Johnson at firstname.lastname@example.org
Internal Number: 321
About Angion Biomedica
Angion Biomedica is a clinical-stage organ restoration biopharmaceutical company focused on renal disease including acute kidney injury and chronic renal disease.We are pioneers in using rational drug design to target the body's protective, reparative and regenerative system for therapeutic benefit. We believe these treatment objectives address significant unmet need in both orphan indications and large clinical landscapes.Our fully integrated multidisciplinary research and development facility is located in Uniondale, NY. The state-of-the-art facility accommodates rational drug discovery, development and clinical operations.