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Regulatory Affairs Associate

BioSpace, Inc.

Leidos Biomedical Research, Inc., Rockville-based, is seeking a Regulatory Affairs Associate to support IND filing readiness and regulatory submissions for translational programs in NCATS collaborations. You will coordinate, write, review, and finalize regulatory documents, manage timelines, and ensure compliance across FDA, Health Canada, and EMA with CROs and NIH partners. The role emphasizes document control, version tracking, and proactive issue resolution in a fast-paced, cross-functional #J-18808-Ljbffr

Vacancy posted 3 hours ago
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