Client Dedicated CMC Regulatory Manager/Senior Manager

🕒 August 20

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 29%

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

• Lead and execute global CMC regulatory strategy and submissions for biological products • Develop and execute CMC regulatory strategies for biological products • Provide CMC regulatory guidance for regulatory submissions to the FDA and Health Canada • Act as primary liaison for CMC regulatory matters related to biologicals • Collaborate with R&D, Quality, Manufacturing, and Global Regulatory teams • Oversee preparation, review, and submission of CMC sections (Module 3) for 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, authoring, review, and coordination of U.S. and Canadian Annual Reports • Lead preparation, authoring, review, and coordination of Canadian Yearly Biologic Product Reports (YBPR) • Author, review, and compile Module 1 documentation for commercial submissions in the U.S. and Canada • Lead CMC regulatory management and dossier authoring for post-approval changes, site transfers, and formulation updates • Ensure continuous regulatory compliance throughout the biological product lifecycle • Manage variations and renewals • Monitor and assess regulatory guidance related to biologics 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 • Excellent 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 • Full-time employment • Standard Monday–Friday work schedule • Equal Employment Opportunity/Affirmative Action protections