Assoc. Dir, Regulatory Affairs-CMC

Role: Associate Principal Scientist for Regulatory CMC Digital Innovation, focusing on developing AI and digital solutions to enhance Regulatory CMC workflows, including authoring, process automation, and digital transformation initiatives. Responsibilities: lead AI-enabled authoring advancements, assess emerging technologies, coordinate cross-functional digital projects, support digital operating models, and advocate for enterprise-wide AI adoption. Serve as system owner for key digital platforms like Veeva and ERA, collaborate across R&D and Manufacturing divisions to identify digital opportunities, and mentor digital project teams. Requirements: BS in a scientific, technical, or regulatory field; minimum 5 years of pharma/biotech experience in Regulatory CMC or related operations; hands-on experience with digital tools, AI/LLM solutions, and process automation; strong change management, collaboration, and project management skills. Preferred: experience in regulated environments involving digital transformation, and proficiency with regulatory platforms. HighValue: digital innovation in Regulatory CMC, AI-enabled authoring, cross-divisional collaboration, 5+ years pharma/biotech experience, regulatory workflows, and system ownership. WorkSetup: hybrid in Rahway, NJ or West Point, PA; up to 10% travel.