Assoc. Dir, Regulatory Affairs-CMC

Role: Associate Principal Scientist, Regulatory CMC Digital Innovation, focusing on developing and implementing digital and AI tools to enhance Regulatory CMC workflows. Responsibilities: lead AI-enabled authoring initiatives, advocate for emerging digital technologies, coordinate cross-functional projects linking regulatory, manufacturing, and R&D divisions, support digital operating models, oversee digital tool integration (e.g., Veeva), serve as primary contact for key platforms, and foster enterprise-wide AI adoption through advocacy, change management, and mentorship. Requirements: minimum BS in a scientific, technical, or regulatory field; 5+ years in pharma/biotech, with hands-on experience developing or deploying digital and AI solutions within regulated environments; proven track record delivering enterprise solutions and change management; strong collaboration and project management skills. HighValue: focus on digital/AI innovations in Regulatory CMC, emphasis on automation, generative AI, and digital transformation; experience with regulatory platforms (e.g., Veeva), and cross-divisional collaboration between research, manufacturing, and regulatory teams. WorkSetup: hybrid in Rahway, NJ or West Point, PA; up to 10% travel.