Regulatory Affairs Specialist – CMC Coordinator

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🔥 11 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 15%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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

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