Overview In this role you will drive digital and AI-enabled initiatives across Regulatory CMC to improve efficiency and compliance. You will collaborate with cross-functional teams to implement innovative tools, operate within a digital operating model, and champion enterprise-wide AI adoption. You will partner with Manufacturing and R&D to deliver integrated, scalable solutions such as AI-enabled authoring and automated processes. This is an opportunity to shape the future of regulatory digital workflows within a global pharma leader. Compensation / Benefitsmedical, dental, visionretirement benefits including 401(k)paid holidaysvacationcompassionate and sick daysannual bonus and long-term incentive (eligible) ResponsibilitiesAdvance AI-enabled regulatory authoring, including Module 2/3 innovations and practical job aidsMonitor and evaluate emerging AI and digital technologies for Regulatory CMC useLead cross-functional activities for AI authoring, automation, regulatory intelligence, and digital transformationSupport the Digital Operating Model to connect local AI efforts with enterprise strategiesCollaborate with Regulatory CMC Systems/Operations on digital solutions (e.g., Veeva)Act as primary contact for key digital tools/platforms (e.g., ERA App) and support priority trackingFoster collaboration across Divisions (R&D, Manufacturing) to identify shared digital opportunitiesAdvocate AI adoption through networks, feedback loops, and training initiativesLead and mentor digital project teams, including internship projects in AI-enabled authoringEducate and disseminate digital practices across GRACS CMC and broader AI community Key requirementsBS or equivalent scientific, technical, or regulatory degreeminimum 5 years in pharmaceutical/biotech with Regulatory CMC or related operationshands-on experience developing/implementing digital tools, automation, and AI/LLM solutions in regulated settingsproven track record delivering enterprise-wide solutions that improve outcomesexperience with change management, end-user training, and job aidsability to mentor colleagues or interns on digital projectsstrong collaboration/communication in a matrix organization across research, manufacturing, ITexcellent organizational and project coordination skills; ability to manage multiple initiativesup to 10% travelcollaborationcommunicationchange managementAI/LLM solutionsRegulatory CMC knowledgedigital tools and automation
Not specified in the original listing.
Not specified in the original listing.
