Remote Associate Director, Regulatory Affairs ANDA/IND

Padagis US LLC seeks a Director or Associate Director of Regulatory Affairs to oversee regulatory strategies and submissions for US-market pharmaceutical products, primarily ANDAs. The role requires leading regulatory efforts across preclinical, clinical, and manufacturing stages and coordinating with internal teams and FDA stakeholders.

The ideal candidate will have 7–10+ years in Regulatory Affairs, with a track record in generic drug regulatory submissions and strong FDA guidance knowledge.