Reporting to the President & CEO, the successful candidate will be responsible for leading and advising regulatory staff on regulatory strategies and compliance activities for drug and biologic development programs, as well as future commercial activities.
- Management oversight of regulatory activities for assigned programs
- Assume lead role in developing and guiding regulatory strategies to support successful development programs and regulatory approvals in oncology indications
- Oversee the preparation of global regulatory development plans (RDPs) outlining strategic plans to achieve rapid oncology product development
- Ensure that all projects have a clearly defined regulatory pathway and milestones leading to successful filings and approvals
- Oversee the development and management of defining key regulatory timelines and regulatory critical path activities
- Supervise and provide guidance for all global health authority communications/ submissions
- Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
- Establish processes with Commercial and Legal to support reviews of promotional material and labeling activities to support future commercial products
- Communicate effectively with the senior management personnel (and external partners, where appropriate)
- BS or BA in a scientific discipline and/or equivalent experience; Advanced degree strongly desired with at least 10 years in Regulatory Affairs in the industry
- Must have experience in small molecule drug development; biologics drug development experience highly desired.
- Experience in preparing regulatory strategies (e.g., regulatory development plans), highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
- Previous experience in a senior regulatory role, including interactions with regulatory agencies (as lead regulatory representative) is desirable
- In-depth understanding of regulations and guidelines governing all phases of drug development (for both drugs and biologics)
- Excellent verbal and written communication skills including presentation skills
- Experience with electronic submission process desirable
AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). Tivozanib (FOTIVDA®) is approved by the European Commission for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland.