Senior Regulatory Affairs Lead, CDx/FDA Submissions
Listed on 2026-10-06
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Pharmaceutical
Regulatory Compliance Specialist, Healthcare Compliance, Medical Science Liaison
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.
As a Senior Regulatory Affairs Lead, CDx/FDA Submissions, you will play an important part at Foundation Medicine in Boston, MA, United States.
Join Foundation Medicine and contribute to our ongoing work.
Take a moment to read everything above and see whether this role is right for you.
This posting is for the Senior Regulatory Affairs Lead, CDx/FDA Submissions role at Foundation Medicine, based in Boston, MA, United States.
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