Regulatory Affairs Specialist, Oncology Therapy Area

Overview

• Regulatory Submissions: Support the preparation, compilation, and maintenance of regulatory submission packages (e.g. Clinical Trial Applications (CTAs) via CTIS, INDs, amendments, annual reports, briefing documents). Coordinate eCTD publishing and document lifecycle management in collaboration with Regulatory Operations or external vendors. Perform quality control checks to ensure submission documents are complete, accurate, and compliant.
• Regulatory Strategy Support: Execute regulatory strategy tasks as defined by senior team members (Regional Regulatory Leads/Global Regulatory Leads). Gather regulatory intelligence to support development decisions. Track regulatory commitments, key milestones, and health authority feedback for ongoing projects.
• Cross-Functional Collaboration: Collaborate closely with Clinical Development, Clinical Operations, Nonclinical Development, Medical Writing, CMC, and external partners to gather necessary data a...