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US Regulatory Affairs Director — Strategy & Submissions
Job in
Waltham, Middlesex County, Massachusetts, 02254, USA
Listed on 2026-09-04
Listing for:
Sironax Ltd.
Full Time
position Listed on 2026-09-04
Job specializations:
-
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Sironax Ltd. seeks a Director, U.S. Regulatory Affairs to lead U.S.
regulatory strategies across development programs and oversee regulatory filings and interactions with FDA. The role collaborates with cross-functional teams on global plans and ensures timely, high-quality regulatory decisions throughout product lifecycle. Responsibilities include planning FDA interactions, managing submissions, and maintaining compliant regulatory records, with a focus on risk-based guidance and leadership
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