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Global Regulatory CMC Strategist
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-08-04
Listing for:
CSL
Full Time
position Listed on 2026-08-04
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
CSL in Massachusetts seeks an experienced Regulatory Affairs leader to shape global regulatory CMC strategy for plasma-derived therapies. You will collaborate with R&D, Quality, Global Operations, and external partners to drive compliant, timely submissions across geographies.
The role emphasizes digital innovation, KPI-driven performance, and change control activities, with oversight of outsourcing, vendor relationships, and regulatory intelligence for FDA, EMA, PMDA, and global agencies.
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