The ideal candidate is a hands-on regulatory professional with strong CMC technical knowledge, a proactive ownership mindset, and a commitment to excellence, who thrives in a fast-paced biotech environment, takes full accountability for assigned programs, effectively partners with cross-functional teams, and consistently delivers high-quality, scientifically sound, and regulatory-compliant outcomes. Demonstrated technical CMC expertise gained through hands-on experience as a subject matter expert in one or more CMC disciplines (e.g., formulation, analytical development, process development, manufacturing, chemistry, pharmaceutical development, or quality), with the ability to independently interpret complex scientific and manufacturing data and translate technical conclusions into sound regulatory strategies.