Replicant Systems
Website:
replicantsys.com
Job details:
Function: Pharma Regulatory Affairs/ Quality Assurance Expert supporting AI Product Development
Reports to: CEO
Location: Hybrid / On-site in Hyderabad
Employment Type: Limited Contract work, with option to convert to full-time
About the Role
Replicant AI is an agentic documentation platform that helps Regulatory & Quality Assurance teams review and draft compliance documents.
We are hiring pharmaceutical Quality/Regulatory professionals to own the regulatory and quality guideline knowledge base that powers the agent's review logic. You will translate global regulatory guidance (FDA, ICH, Health Canada, EMA, WHO, and related bodies) and client SOPs into structured, machine-readable rule sets, and you will review and validate the AI's review comments/output against those rules and against real pharma reports.
Key Responsibilities
- Develop structured regulatory validation rule datasets by extracting and interpreting requirements from official FDA, ICH, Health Canada, and other global agency guidance documents.
- Convert agency and SOP guidance into a machine-readable, structured rule format (e.g., rule ID, requirement text, category, severity, effective date, source citation) that can be consumed by the AI review module.
- Verify every extracted rule against the official source document to maintain accuracy, source traceability, and audit-ready documentation.
- Identify and correct duplicate, incomplete, ambiguous, or inconsistent rule entries by re-reviewing guidance wording, effective dates, severity classification, and validation category assignments.
- Review the AI agent's generated review comments on documents such as Process Validation protocols/reports, Stability Summaries, Analytical Method Validation (AMV) reports, OOS/OOT investigations, CAPAs, Deviations, and Root Cause Analyses — assessing them for regulatory/technical accuracy, relevance, and completeness against rules and source data.
- Provide structured, actionable feedback to the product and engineering teams to improve rule coverage, reduce false positives/negatives, and refine the agent's review logic.
Educational Qualifications
- Bachelor's or Master's degree in Pharmacy (B.Pharm/M.Pharm), Pharmaceutical Sciences, Pharmaceutical/Chemical Engineering, Chemistry, Life Sciences, or a related discipline.
- Additional certification/diploma in Regulatory Affairs, Quality Assurance, or Drug Regulatory Affairs (e.g., RAC, PGDRA) is a plus.
Experience
- Hands-on experience in Pharmaceutical Quality Assurance, Quality Control, or Regulatory Affairs, with direct exposure to reviewing/authoring documents such as Process Validation protocols/reports, Stability Studies, Analytical Method Validation, OOS/OOT investigations, CAPA, Deviations, and Root Cause Analysis.
- Demonstrated experience interpreting and applying FDA, ICH, and/or Health Canada guidance documents in a regulated pharma environment (GMP/GxP setting).
What Success Looks Like
- A rule set that is accurate, current, fully traceable to source guidance, and free of duplication or ambiguity.
- AI-generated review comments that are consistently validated (or corrected) against the correct regulatory rationale, improving the model's precision over time.
- Clear, well-documented rule change logs that would hold up to an internal or client audit.
About Replicant
Replicant is building the documentation intelligence layer for life sciences. Our AI platform drafts, reviews, and manages regulatory, quality, and R&D documents for pharma, biotech, CROs, CDMOs, and medical device teams. Every output traces back to source data, keeps a human in the loop, and is built for GxP compliance (21 CFR Part 11, immutable audit trails). We're an early-stage team working with our first design partners and advised by prominent life sciences leaders. Our experts shape the product directly and work alongside the CEO and engineering team.
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