In this role, you will serve as the primary scientific and operational lead for outsourced quantitative bioanalytical activities at Contract Research Organisations (CROs) ensuring high-quality assay execution, regulatory compliance
You will identify compliance gaps, guide investigations, and lead improvements that support reliable laboratory processes. You will also share your expertise and help teams prepare for regulatory inspections. Lead improvement projects with QC, Quality
Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, integrating inputs from regulatory team and cross functional partners to build globally aligned
Act as a Program Lead to provide oversight of a program within the organization providing oversight to a group of studies and Data Management Leads ensuring that the studies within the program are delivered per corporate goals and objectives.