Regulatory Affairs Specialist – Regulatory CMC Coordinator

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Provide operational and administrative assistance to the Regulatory CMC team.

• Ensure timely, accurate, and inspection-ready CMC documentation for both global and local regulatory submissions.

• Collaborate with Regulatory CMC Leads, Regulatory Operations, Quality, and external partners.

• Aid in the compilation and maintenance of IMPDs, including redline versions.

• Generate CMC-specific inquiries in RIMAS and for Clinical Trial Applications.

• Draft CMC response documents, cover letters, forms, and other submission-related administrative paperwork.

• Develop and manage CMC submission content plans.

• Prepare CMC manufacturing operations and manufacturing parameter data within RIMS.

• Ensure CMC documents are ready for electronic submission, including facility information, floor plans, and supporting materials.

• Assist in quality control of submission output for Module 3 and Module 2.3.

• Create and maintain both master and country-specific IMPD binders.

• Monitor GMP certificates and Manufacturing Import Authorizations, including apostilled versions.

• Facilitate the procurement of literature and the organization of supporting references.

• Review registration data and active dossier information to pinpoint discrepancies and missing details.

• Coordinate the review and approval of assigned workflows and data updates with Regional CMC Leads.

• Maintain regulatory information and metadata within RIMAS and other regulatory systems.

• Reconcile CMC submission trackers with RIMS submission events and records.

• Ensure consistency and accuracy between regulatory planning tools and submission databases.

• Provide administrative support to the department, including the management and maintenance of regulatory documents, tools, and websites.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related discipline.

• Experience in 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.

• Proficiency 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.

• Strong organizational and planning abilities.

• Keen attention to detail.

• Commitment to data accuracy.

• Strong collaboration and teamwork skills.

• Awareness of regulatory compliance.

• Problem-solving skills.

• Commitment to continuous improvement.

• Occasional drives to site locations may be necessary.

• Potential for occasional travel required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.

• Potential for occasional travel required.

• Opportunities for collaboration and professional development.

• Global team environment.

• Workplace focused on scientific excellence.