Senior Manager / Associate Director, Regulatory Affairs CMC

The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining and executing global CMC regulatory strategies for assigned investigational and/or marketed assets. The role partners closely with technical, quality, supply and program teams to communicate regulatory strategies and deliver scientifically sound, submission ready CMC content using a risk based approach. This individual demonstrates exceptional scientific writing, precision, and attention to detail, applies creative thinking and a collaborative, high quality approach that ensures data integrity, regulatory compliance, and trust with cross functional partners and health...