Tech Stack

Description

You will lead regulatory submission publishing and management for a clinical-stage oncology company, ensuring compliant eCTD submissions to global health authorities. You'll partner cross-functionally to optimize regulatory systems, processes, and documentation, driving efficiency and scalability in a fast-paced environment.

Requirements

• Bachelor's degree in life science or related field with 8+ years regulatory operations/pharma experience
• Expert-level proficiency in Microsoft Word, Adobe Acrobat Professional, Toolbox, StartingPoint
• Thorough understanding of eCTD publishing standards and submission regulations
• Experience with FDA submissions and global health authority interactions

Responsibilities

• Oversee planning, publishing, submission, and archiving of regulatory dossiers in eCTD format
• Manage submission production and quality control processes ensuring compliance
• Provide technical expertise in eCTD publishing tools (e.g., Veeva Vault RIM)
• Support implementation and optimization of regulatory systems and tools
• Develop and improve SOPs, templates, style guides, and document standards