Regulatory Affairs Specialist Small Molecule

Job Title: Clinical Regulatory Affairs Specialist - Small MoleculeLocation: RemoteJob Summary:We are seeking an experienced Clinical Regulatory Affairs Specialist with a strong background in clinical regulatory affairs, Trial Master File (TMF) management, and small molecule drug development. The ideal candidate will have extensive experience supporting global clinical trials, preparing regulatory submissions, and ensuring compliance with FDA, EMA, Health Canada, and ICH guidelines. While familia

Job Title:Regulatory Specialist Location:Rosemont, IL - Remote Duration: Long Term Contract Key Responsibilities: Provide strategic input and technical guidance on regulatory requirements to R&D project teams. Develop and implement regulatory strategies to facilitate the progress of US and Global programs and initiatives for the company. Evaluate regulations, establish framework, and design and implement science-based registration strategies for company products to ensure rapid, high-quality s

Description: Remote Our client seeks a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high profile molecules and lifecycle management. The role focuses on operational submission content planning for Modules 1-5, coordination of global submissions and urgent authority requests, and partnership across geographies to ensure compliance with evolving eCTD requirements. The position reports to the Head of Regulatory Operations Clinical and Publishin

Description: Remote Our client is seeking an eTMF Specialist to support a biannual review of Phase Trial Master Files. The specialist will ensure TMFs are complete, accurate, compliant, and inspection-ready through comprehensive quality review and collaboration with internal and external stakeholders. Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefi