Regulatory Affairs Subject Matter Expert

4 weeks ago

Hyderabad, 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 / account management are valued.
- Exposure to digital transformation, workflow automation, or AI-driven products is a big plus

What’s on offer:

- Full-time role with high ownership in a fast-growing AI startup
- Opportunity to define and launch AI-first products for pharma workflows
- Work closely with engineering, design, and leadership teams to build industry-defining solutions
- Agile, entrepreneurial, and collaborative culture with strong growth potential

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