Client Dedicated CMC Regulatory Manager – FDA

🔥 3 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

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

• Lead and execute global CMC regulatory strategy and submissions for biological products • Ensure delivery of high-quality CMC dossiers compliant with US and Canadian regulatory requirements • Provide CMC regulatory guidance for biologics submissions to the FDA and Health Canada • Serve as primary liaison for biological CMC regulatory matters with R&D, Quality, Manufacturing, and Global Regulatory teams • Oversee preparation, review, and submission of CTD Module 3 sections for biological products, including MAAs and variations • Author, compile, and maintain CTD Module 3 content • Coordinate responses to CMC-related questions and deficiencies from health authorities • Perform regulatory impact assessments for CMC change controls and quality events • Lead preparation and coordination of US and Canadian Annual Reports and Canadian Yearly Biologic Product Reports • Author, review, and compile Module 1 documentation for US and Canadian commercial submissions • Lead CMC regulatory management and dossier authoring for post-approval changes, manufacturing process changes, site transfers, and formulation updates • Ensure ongoing regulatory compliance throughout the biological product lifecycle, including variations and renewals • Monitor and assess biologics regulatory guidance and provide strategic input into regulatory filings

🎯 Requirements

• Master's degree or PhD in biotechnology, pharmaceutical sciences, or bioengineering • Minimum 10 years of relevant expertise in CMC development and CMC regulatory for biological products • Extensive knowledge of global regulations, including EMA regulations, ICH guidelines, and specific CMC regulatory requirements for biologics • Proven experience leading CMC regulatory submissions for biological products, including initial MAA submissions and post-approval lifecycle management • Strong understanding of biologics manufacturing, characterization, comparability, and analytical testing requirements • Strong project management skills with the ability to manage complex projects and timelines • Strong communication and interpersonal skills • Experience working in cross-functional and international teams

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Equal employment opportunity and affirmative action employer • Diverse experiences, backgrounds, and perspectives valued

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