FSP Regulatory Affairs Specialist – CMC Compliance Officer

🔥 14 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

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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

• Facilitate Compliance activities within the TechOps team in collaboration with Product Quality and the External Manufacturing network • Ensure cross-functional alignment for critical Compliance topics and projects • Maintain dashboards and keep compliance operations on track • Resolve potential issues affecting timely assessment and closure of actions • Maintain change control trackers and coordinate implementation dates with CMOs • Facilitate cross-functional change control meetings and monitor completion of change actions • Coordinate with Supply Planning for impacted post-change batches • Align multi-asset changes per site with Quality • Manage the Change Control Review Board • Establish and maintain deviation trackers and pursue critical deviation actions with CMOs • Build a system for adequate deviation management in partnership with Quality • Extract applicable change controls for annual reports by asset and jurisdiction • Facilitate cross-functional annual report drafting and review • Maintain health authority commitment trackers and timelines per asset • Coordinate actions and technical activities to initiate studies in time for submission data generation • Track execution of regulatory commitments with the Reg CMC team • Coordinate excipient material and supplier choices to meet regional pharmacopoeia requirements and compendial updates • Prepare regular compliance dashboards • Compile technical documentation, review regulatory requirements, support regulatory submissions, and contribute to product lifecycle management

🎯 Requirements

• Degree in biotechnology, pharmaceutical sciences or bioengineering • Relevant expertise in CMC Project Management or Quality & Compliance background, or a similar role within the Biotech industry • Knowledge of medical device and IVD regulations (EU MDR/IVDR, FDA, international requirements) • Experience with regulatory submissions and documentation management • Strong technical writing and documentation skills • Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and preferably with document management systems • Excellent organizational abilities and attention to detail • Strong analytical and problem-solving capabilities • Effective verbal and written communication skills in English • Ability to work both independently and collaboratively in a matrix environment • Experience with regulatory databases and submission systems preferred • Knowledge of GMP, ISO 13485, and quality management systems • Ability to manage multiple projects and meet deadlines • Customer-focused mindset with strong interpersonal skills • Demonstrates company values of Integrity, Intensity, Innovation, and Involvement • Team player; able to build effective relationships with internal and external stakeholders • Leadership and communication skills • Experience in operations, planning, project management, and tracking projects with high complexity and risk, including clearly defined critical paths • Experience managing projects across global locations and time zones, as well as working effectively in diverse cultural and international environments • Well organized and able to handle multiple assignments in parallel • Eye for detail and quality conscious attitude • Proactive – can do mentality

🏖️ Benefits

• Fully remote work arrangement • Professional development opportunities • Resources to support individual career goals

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