Remote Regulatory Affairs Director – FDA Submissions

Job description

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies and submissions for U.S. market products, including generics. The role requires guiding INDs, NDAs, ANDAs and post-approval commitments while coordinating with R&D, QA, and Manufacturing teams.

The position emphasizes risk assessment, regulatory leadership across development stages, and responsibility as FDA liaison. Remote work is eligible for U.S.

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Who can apply

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