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Years of regulatory and/or CMC experience:
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Areas of Expertise (check all that apply):
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Biologics
Biosimilars
Cell Therapy
CMC
Gene Therapy
Early stage development (through Phase 1)
Mid stage development (IND - Phase 2)
Late stage development (Phase 3 - Marketing applications)
Project Management
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Regulatory Strategy - USA
Regulatory Strategy - EU
Regulatory Strategy - Canada
Regulatory Strategy - Japan
Regulatory Strategy - Global
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