Regulatory Affairs Specialist – CMC Coordinator

• Provide operational and administrative support to the Regulatory CMC team
• Support timely, accurate, and inspection-ready preparation of CMC documentation for global and local regulatory submissions
• Work with Regulatory CMC Leads, Regulatory Operations, Quality, and external partners to coordinate submission content
• Maintain regulatory records and support dossier preparation activities
• Support compilation and maintenance of IMPDs, including preparation of redline versions
• Assist with CMC-specific questions in RIMAS and for Clinical Trial Applications
• Draft CMC response documents, cover letters, forms, and other submission-related administrative documents
• Create and maintain CMC submission content plans for submission planning and document tracking
• Prepare CMC manufacturing operations and manufacturing parameter data within RIMS
• Ensure CMC documents are electronic submission-ready, including facility information, floor plans, and supporting documents
• Assist with quality control of submission output for Module 3 and Module 2.3
• Create and maintain master and country-specific IMPD binders
• Maintain tracking of GMP certificates and Manufacturing Import Authorizations, including apostilled versions
• Facilitate procurement and organization of literature and supporting submission references
• Review registration data and active dossier information to identify discrepancies and missing information
• Coordinate with Regional CMC Leads on workflow and data-update reviews and approvals
• Maintain regulatory information and metadata within RIMAS and other regulatory systems
• Collaborate with Regulatory Operations to reconcile CMC submission trackers with RIMS submission events and records
• Ensure consistency and accuracy between regulatory planning tools and submission databases
• Provide administrative support for regulatory documents, tools, and websites

• Bachelor's degree in Life Sciences or a related field (preferred qualification)
• Experience supporting CMC regulatory submissions and/or Clinical Trial Applications
• Familiarity with IMPDs, CTAs, GMP documentation, and regulatory document management processes
• Experience with AI and comfort operating in AI-enabled environments
• Experience with electronic document management systems such as Veeva RIM or similar platforms
• Knowledge of electronic submission requirements and document publishing standards
• Experience with eCTD or other electronic submission environments
• Organization and planning skills
• Attention to detail
• Data accuracy
• Collaboration and teamwork
• Regulatory compliance awareness
• Problem-solving skills
• Continuous improvement mindset
• Occasional ability to drive to site locations
• Potential occasional travel

• Fully remote work mode
• Standard Monday–Friday work schedule
• Occasional travel opportunities
• Collaboration and professional development environment
• Passion, innovation, and scientific excellence culture