This hands-on role is suited for an experienced scientific or technical writer who can translate complex CMC, pharmaceutical development, and drug-device combination product information into concise, traceable, and scientifically defensible documents that support program knowledge management, regulatory readiness, and submission deliverables. Lead and support CMC content development for regulatory submissions and health authority interactions, including INDs, IMPDs, CTAs, briefing packages, regulatory responses, Master Validation Plans, and related submission content, in partnership with Regulatory Affairs and CMC subject matter experts.