Senior Regulatory Affairs Lead, CDx/FDA Submissions
Foundation Medicine Inc
Foundation Medicine in Boston seeks a Senior Specialist, Regulatory Affairs (CDx) to lead regulatory submissions, shape strategy, and guide cross-functional teams through FDA pathways for companion diagnostics. You will prepare packages, respond to agency inquiries, review validation data, and ensure compliance across regulatory activities, with emphasis on clear scientific writing and collaboration. The role also emphasizes strong communication and meticulous work. #J-18808-Ljbffr Foundation Medicine
Vacancy posted 3 days ago
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