Intern - PDM - CMC Regulatory Affairs, Strategy and Operations
Core
Intern supporting the design and development of an AI-enabled capability to simulate health authority reviews of CMC regulatory submissions.
Role type
Intern, AI/Regulatory Strategy
Builds
Early-stage AI prototype for regulatory simulation
Domain
Pharmaceutical Regulatory Affairs + Artificial Intelligence
Deliverable
production ML models
Required skills
Research, structured information synthesis, problem-solving, data analysis, regulatory guidance interpretation
Preferred skills
Generative AI, large language models, data science, automation, statistical programming, epidemiology, biostatistics, chemical engineering
Technologies
Microsoft Office (Word, Excel, PowerPoint, Outlook), generative AI, large language models
Responsibilities
Support definition and early design of governed AI capability for health authority review simulation; Research health authority guidance and regulations; Support development and testing of MVP/prototype; Develop approaches for evaluating AI output quality; Support Regulatory Policy colleagues in assessing emerging requirements; Present final work
Seniority
Intern