Associate Director, Regulatory Ops — Submissions & Systems

Posted yesterday

akebia therapeuticsWaltham (MA)

Regulatory Affairs Managers Pharmaceutical Preparation Manufacturing

SENIORITY

Manager

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About the role

Akebia Therapeutics, Inc. is seeking an Associate Director of Regulatory Operations in Waltham, MA. The role leads submissions, governance, and dashboarding to enable efficient regulatory activity across global programs. The candidate will drive eCTD 4.0 readiness, establish scalable processes, and partner with functional teams to ensure inspection-ready records and timely information governance. Hybrid work arrangement is available.

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