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Jobs in bengaluru
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Randstad
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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

12 - 22 years

|

19 - 27 Lacs

Bengaluru

Posted:1 week ago| Platform:

Apply

Skills Required

regulatory compliance fda regulatory affairs gmp compliance gmp

Work Mode

Hybrid

Job Type

Full Time

Job Description

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

10 years of hands-on experience

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