Remote Regulatory Affairs Lead: FDA Submissions & Strategy

Job description

Padagis US LLC seeks a Director/Associate Director of Regulatory Affairs to lead regulatory strategy, submissions, and writing for US products, primarily ANDAs for generics. You will guide development and coordinate with R&D, Quality, and Manufacturing to ensure timely FDA filings.

This remote role is open to candidates nationwide with preference for the Minneapolis–St. Paul area; you will mentor staff and ensure compliant, high-quality submissions.

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Worksite address

waunakee, WI, 53597, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.