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Job description
Role: Senior Scientist (R3) in Regulatory CMC Biologics, leading global regulatory strategies and project management for biological products throughout development and post-approval.
Responsibilities: develop and execute robust CMC regulatory plans, manage documentation such as INDs, BLAs, and post-approval variations, ensure compliance with global agency requirements, and escalat(>???) issues as needed.
Requirements: B.S. in a science or engineering field; 5+ years in Regulatory CMC, with biological or vaccine product experience preferred.
High-Value: biologics, vaccines, Regulatory CMC, global product lifecycle management, regulatory documentation, compliance, experience with eCTD; hybrid work setup; US-based with potential travel.
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Worksite address
rahway, NJ, 07065, US
Who can apply
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