Client Dedicated CMC Regulatory Manager/Senior Manager

Job not on LinkedIn

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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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 • Provide CMC regulatory guidance for regulatory submissions to the FDA and Health Canada • Liaise on CMC regulatory matters related to biologicals with R&D, Quality, Manufacturing, and Global Regulatory teams • Oversee preparation, review, and submission of CMC sections (Module 3) 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, authoring, review, and coordination of Annual Reports for U.S. and Canadian marketing applications • Lead preparation, authoring, review, and coordination of Yearly Biologic Product Reports for Canadian marketing • 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, manufacturing process changes, site transfers, and formulation updates • Ensure continuous regulatory compliance throughout the biological product lifecycle • 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 and ICH guidelines • Knowledge of 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 • Strong communication and interpersonal skills • Experience working in cross-functional and international teams

🏖️ Benefits

• EEO/Affirmative Action protections • Reasonable accommodation for individuals with disabilities • Diverse experiences, backgrounds and perspectives valued