Regulatory Affairs Subject Matter Expert

7 days ago


Hyderabad, Telangana, India Replicant Systems Full time

We are an AI-native startup building AI for regulatory compliance in the pharmaceuticals and life sciences sector . We're looking for a deep subject matter expert in regulatory affairs for Pharma / Life Sciences to join our core team. This role combines domain expertise with product leadership , making you the bridge between industry workflows and cutting-edge AI solutions.

What you'll bring:

Strong expertise in Life Sciences / Pharma / Biotech / MedTech processes, regulations, and workflows. Knowledge of IND/NDA/ANDA/DMF filings, eCTD publishing, correspondence with USFDA/EMA/PMDA, handling global submissions, variations, labelling, and compliance audits. Mindset : Open to tech-driven disruption , not rigidly traditional. Secondary skills in consulting /

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