Associate Director, Regulatory Affairs

The Associate Director, Regulatory Affairs will join a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the product pipeline. This role provides regulatory support for oncology products in early-stage and late-stage development through post-approval. Additionally, the Associate Director is responsible for the oversight of clinical trial investigational new drug applications (INDs), clinical trial applications (CTAs), and marketing applications (BLAs and NDAs)ResponsibilitiesDevelop regulatory strategies for oncology development programsProvide solid regulatory solutions and guidance to cross-functional teams and senior managementMonitor global regulatory changes that may impact asset developmentEnsure compliance of regulatory strategies and submissions