Assoc. Dir, Regulatory Affairs-CMC
Core
Develop and implement digital and AI innovations to enhance Regulatory CMC workflows, authoring, and operational excellence within a global healthcare company.
Role type
Associate Director, Regulatory CMC Digital Innovation
Builds
AI-enabled regulatory authoring tools, digital transformation solutions, and integrated cross-functional platforms for Regulatory CMC.
Domain
Pharmaceutical/Biotech Regulatory Affairs and Digital Innovation
Required skills
Regulatory CMC, Regulatory Affairs Management, Change Management, Project Leadership, eCTD, Manufacturing Processes, Regulatory Compliance, Regulatory Reporting, Emerging Technologies, Technical Change Management
Preferred skills
AI/LLM solution development, Data Analytics, Computer Science
Technologies
Veeva, ERA App, Generative AI, Machine Learning
Responsibilities
Drive AI-enabled regulatory authoring capabilities and identify generative AI drafting opportunities; Assess emerging AI and digital tools for utility in Regulatory CMC processes; Lead cross-functional activities for digital transformation and process automation; Partner with Systems/Operations to develop digital solutions for regulatory platforms; Serve as primary point of contact for key digital tools and platforms; Collaborate across R&D and Manufacturing divisions to co-develop cross-functional solutions; Champion enterprise-wide AI adoption and drive change management activities; Mentor digital project teams and guide intern projects focused on AI-enabled authoring.
Seniority
Senior, hands-on IC with strategic enablement focus