Regulatory Affairs Specialist (Hyderabad)

Cheiron is a Stanford-based AI company building the AI-native operating system for drug development.

Biopharma knowledge work is structurally fragmented. Critical decisions depend on stitching together evidence across literature, clinical trials, regulatory precedent, and patentsspread across disconnected systems. Cheiron replaces this paradigm with a unified intelligence layer: our proprietary Lifesciences Knowledge Graph (LKG), which integrates and structures these data sources into a single, continuously evolving system of record.

On top of this foundation, Cheiron deploys workflow-native AI agents that execute real-world R&D, clinical, and regulatory tasks end-to-endwith full traceability and scientific rigor.

Since launching in 2024, Cheiron has achieved rapid global adoption. In Korea, we reached 22% of the biopharma knowledge workforce across 200+ organizations within six months. In the United States, within two months of launch, we onboarded thousands of professionals across hundreds of biopharma companies, driven by strong organic demand.

Cheiron is proudly pre-VC, backed by a $6M+ angel round from globally recognized investors, including leaders from the SK and Samsung families and co-authors of Attention Is All You Need.

As we scale our U.S. presence, we are expanding a deeply interdisciplinary team at the intersection of AI, life sciences, and real-world drug development workflows.

We are seeking a Regulatory Affairs Specialist to help define and operationalize how regulatory intelligence, strategy, and submission workflows are executed within Cheiron.

This role is designed for individuals with deep experience in global regulatory frameworks (FDA, EMA, ICH) who understand the nuances of regulatory decision-makingfrom early strategy through submission and lifecycle managementand are motivated to translate those workflows into AI-native systems.

You will act as both a domain expert and product shaper, ensuring Cheiron accurately reflects real-world regulatory practices while enabling step-function improvements in speed, traceability, and rigor.

Apply Cheiron to core regulatory workflows, including:

• Regulatory strategy development (IND, NDA/BLA, MAA)
• Pre-IND/Scientific Advice preparation
• Labeling strategy and precedent analysis
• Regulatory intelligence and guidance tracking

Evaluate AI outputs for:

• Alignment with regulatory guidance and precedent
• Completeness and defensibility of regulatory rationale
• Risk identification (gaps, inconsistencies, compliance issues)

Systematically structure regulatory knowledge into reusable frameworks:

• Guidance interpretation schemas
• Submission component logic (e.g., Module 25 narratives)
• Precedent-based reasoning patterns

Collaborate with product and AI teams to:

• Improve regulatory reasoning fidelity
• Define agent workflows for submission preparation and review

Contribute to benchmark datasets and validation cases for regulatory decision-making

This role is designed for regulatory professionals who have a deep understanding of global regulatory strategy and submission workflows, and who are interested in translating that expertise into AI-native systems.

• Regulatory Affairs professionals with experience in IND, NDA/BLA, or MAA submissions
• Individuals with hands-on experience in regulatory strategy, agency interactions (FDA/EMA), and lifecycle management
• Clinical or translational scientists who have worked closely with regulatory teams on submissions or regulatory decision-making
• Regulatory consultants or analysts with strong experience in regulatory intelligence and precedent analysis
  

• Experience in Regulatory Affairs within pharma/biotech (industry or consulting)
• Strong familiarity with FDA/EMA/ICH frameworks and submission processes
• Experience supporting IND/NDA/BLA or equivalent submissions
• Ability to critically evaluate regulatory arguments and evidence
• Strong written communication with emphasis on regulatory clarity and precision
  

This full-time role offers $200k - $250k in total compensation, including performance-based bonus. Compensation is determined by experience, expertise, and role alignment. Benefits include competitive healthcare, equity participation, and the opportunity to work closely with a world-class interdisciplinary team.