summary

job details

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, and acting as a trusted regulatory advisor.
Startup Impact: Working closely with the founding and engineering teams to build a product that influences how AI supports regulatory judgment globally.

20 ...

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, and acting as a trusted regulatory advisor.
Startup Impact: Working closely with the founding and engineering teams to build a product that influences how AI supports regulatory judgment globally.

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senior regulatory affairs leader.

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