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Padagis

Remote Associate Director, Regulatory Affairs – ANDA Focus

lunenburg, MA

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Job description

Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies, submissions and writing for US generic products (ANDA/IND/NDA). The role is remote eligible for US residents, with preference for candidates in the Minneapolis–St. Paul area.

You will lead cross‑functional teams, liaise with the FDA, plan submission timelines, and guide development to secure timely FDA approvals while ensuring post‑marketing compliance and REMS coordination.

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Worksite address

lunenburg, MA, 01462, US

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