Global CMC Regulatory Lead – Biologics Submissions
Listed on 2026-10-09
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Research/Development
Regulatory Compliance Specialist
Thermo Fisher Scientific is seeking a senior professional to lead CMC regulatory strategy and submissions for biological products. You will act as the SME for biologics, guiding regulatory submissions to the FDA and Health Canada, and coordinate with R&D, QA, manufacturing and global regulatory teams.
The role covers post-approval lifecycle management, including annual reports and post-approval changes, ensuring full compliance with US and Canadian requirements and CTD Module 3 content.
As a Global CMC Regulatory Lead – Biologics Submissions, you will play an important part at NCBiotech in NC, United States.
We aim to respond to suitable candidates as soon as possible.
Full responsibilities and requirements are described in the listing above.
Learn more about the Global CMC Regulatory Lead – Biologics Submissions role in the description above.
We appreciate your interest in this position.
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