Reporting to the Senior Vice President of Regulatory Affairs, 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 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
- Lead global health authority communications and preparation of submissions for assigned programs
- 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 Vice President of Regulatory Affairs and other senior management personnel (and external partners, where appropriate)
- BS or BA in a scientific discipline and/or equivalent experience; Advanced degree strongly desired with 10+ years in industry and at least 5+ years in Regulatory Affairs
- 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 Pharmaceuticals is a biopharmaceutical company seeking to advance targeted medicines for oncology and other unmet medical needs. The Company’s lead candidate is tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, which AVEO is working to develop and commercialize in North America as a treatment for renal cell carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers. Tivozanib (FOTIVDA®) is approved by the European Commission for the treatment of adult patients with advanced RCC in the European Union plus Norway, New Zealand, and Iceland. AVEO is leveraging or seeks to leverage partnerships to develop and commercialize its pipeline of products and product candidates, including tivozanib in oncology and other indications in various geographies, and ficlatuzumab (HGF MAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia. AVEO’s earlier-stage pipeline includes AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb) for various oncology indications.