Job Description

Key responsibilities include:Regulatory & Product Leadership: Acting as the in-house regulatory authority, translating global guidelines (ICH, FDA, EMA) into product requirements and AI workflows.Submissions & Lifecycle Expertise: Shaping and validating systems that support end-to-end global regulatory submissions (ANDA, DMF, IND, MAA, etc.).Customer Success & Implementation: Directly leading customer implementations, supporting them during active filings,

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