Regulatory Affairs Specialist – Regulatory CMC Coordinator

🔥 3 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.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

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide operational and administrative support to the Regulatory CMC team • Coordinate timely, accurate, and inspection-ready CMC documentation for global and local regulatory submissions • Work with Regulatory CMC Leads, Regulatory Operations, Quality, and external partners • Support compilation and maintenance of IMPDs, including redline versions • Create CMC-specific questions in RIMAS and for Clinical Trial Applications • Draft CMC response documents, cover letters, forms, and submission-related administrative documents • Create and maintain CMC submission content plans • 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 • Track GMP certificates and Manufacturing Import Authorizations, including apostilled versions • Facilitate literature procurement and organization of supporting references • Review registration data and active dossier information to identify discrepancies and missing information • Coordinate 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 management and maintenance of regulatory documents, tools, and websites

🎯 Requirements

• Bachelor's degree in Life Sciences or a related field • 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 • Continuous improvement • Occasional drives to site locations • Potential occasional travel required

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Potential occasional travel required • Collaboration and development opportunities • Global team environment • Scientific excellence-focused workplace