Solution Architect with strong Pharma Regulatory domain expertise

Solution Architect with strong Pharma Regulatory domain expertise

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, modernJavaScript/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.

Preferred Experience Experience supporting regulatory modernization, RIM transformation, regulatory intelligence, submission automation, or labeling transformation initiatives. Hands-on Solution Architect who combines Pharma Regulatory domain understanding with modern technology leadership. This person should be able to consult with business users, translate requirements into future-ready architecture, build quick POCs, guide distributed teams, support presales, and continuously introduce innovative technologies that improve product performance, endurance, scalability, and business value. Experience with GenAI-enabled solutions such as regulatory document summarization, health authority query response automation, change impact analysis, intelligent search, and knowledge assistants. Knowledge of Agile delivery, product-oriented delivery models, architecture governance, and enterprise architecture artifacts. Relevant architecture certifications such as AWS Certified Solutions Architect, Azure Solutions Architect, TOGAF, or equivalent are desirable.