Role Overview:
We are looking for an experienced hands-on Solution Architect with strong Pharma Regulatory domain expertise to drive solutioning, architecture design, and technology advisory for regulatory transformation initiatives. The candidate should be able to engage directly with business users, understand regulatory business processes and pain points, translate requirements into scalable technology solutions, and present a clear point of view to stakeholders. This role requires a strong understanding of the Pharma Regulatory tools and applications ecosystem, along with the ability to introduce innovative, secure, and automation-led solutions aligned to business outcomes.
Required Domain Expertise:
• Strong working knowledge of Pharma Regulatory Affairs processes and operating models.
• Understanding of regulatory submissions, dossier management, product registration, regulatory intelligence, labeling, health authority correspondence, commitment tracking, and compliance monitoring.
• Knowledge of global regulatory agency expectations and frameworks such as FDA, EMA, ICH, and GxP/data integrity principles.
• Experience with regulatory transformation programs involving workflow automation, regulatory data integration, reporting, and process simplification.
• Ability to work with regulatory business users and convert functional needs into clear architectural designs and delivery-ready requirements.
Required Skills and Qualifications:
• 15+ years of overall IT experience, with significant experience in solution architecture, enterprise application design, and regulatory/life sciences technology programs.
• Proven experience working in Pharma Regulatory or Life Sciences domain, preferably with global regulatory affairs teams.
• Strong ability to conduct requirement workshops, facilitate discussions, ask relevant business and technology questions, and document solution assumptions and design decisions.
• Excellent communication and presentation skills with the ability to explain complex architecture concepts to business and technology stakeholders.
• Strong analytical mindset with the ability to assess current-state architecture, identify gaps, and recommend pragmatic target-state solutions.
• Experience in designing secure, scalable, high-performing, and compliant enterprise applications.
• Ability to work with cross-functional and multi-location teams including business users, architects, developers, testers, data teams, security, quality, and vendors.
• Strong ownership mindset, consulting orientation, and ability to influence stakeholders through structured recommendations and solution point of view.
• Hands-on experience with LangGraph or similar agent orchestration frameworks, observability platforms, prompt engineering, evaluation frameworks, and AI governance considerations.
• Strong full-stack engineering knowledge across MERN stack, modern JavaScript/TypeScript frameworks, Node.js, REST APIs, microservices, and third-party API integrations.
• Strong database and data architecture experience across RDBMS, NoSQL (Marklogic) databases, search platforms, data pipelines, and scalable integration patterns.
• Deep understanding of AWS services, cloud-native architecture, serverless patterns, containerization, CI/CD pipelines, DevSecOps practices, security, monitoring, and infrastructure automation.
• Excellent communication, consulting, presentation, negotiation, and stakeholder management skills.
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