The Associate Director will own the operational backbone of global regulatory filings, including the planning, publishing, and delivery of submissions to health authorities. They will also serve as the business owner for the Regulatory Information Management System (RIMS) and manage partnerships with CROs and vendors.
Manage contract drug substance and drug product analytical development, quality control activities, and stability programs. Collaborate with internal teams and CDMOs to ensure regulatory compliance, oversee investigations, and support batch release processes.
Own and evolve the core platform architecture across the data layer, API, and frontend while writing production code daily. Establish engineering standards, mentor other engineers, and ensure high security and performance benchmarks are met.
