Only W2 || Hybrid || Solution Architect with strong Pharma Regulatory domain expertise || Raritan, New Jersey

Hello

Role Overview

• Engage with business users, product owners, regulatory stakeholders, and technology teams to understand business objectives, current-state processes, pain points, and solution needs.
• Define end-to-end solution architecture for Pharma Regulatory platforms, including application architecture, integration architecture, data flows, security considerations, and deployment approach.
• Translate business requirements into scalable, flexible, secure, and supportable technology solutions across regulatory affairs, submissions, regulatory intelligence, labeling, health authority interactions, and compliance workflows.
• Develop and present solution options, architecture recommendations, point of view documents, and roadmap inputs to business and technology leadership.
• Hands-on quick POC creation using wide verities of technologies
• Provide thought leadership on process automation, integrating regulatory systems, and leveraging AI/GenAI where appropriate.
• Collaborate with enterprise architects, security teams, quality teams, platform owners, engineering leads, and vendors to ensure architecture alignment with enterprise standards and regulatory compliance needs.
• Guide development teams during design and implementation to ensure adherence to approved architecture, non-functional requirements, reusable patterns, and best practices.
• Identify opportunities to introduce innovative solutions such as intelligent automation, regulatory document intelligence, advanced analytics, workflow orchestration, and AI-assisted regulatory operations.
• Support estimation, solution proposals, architecture reviews, and client-facing technical discussions.
• Ensure solutions are designed with appropriate focus on data integrity, auditability, traceability, role-based access, security, scalability, performance, and maintainability.

• 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.

• Familiarity with Regulatory Information Management systems, regulatory submission platforms, document management systems, labeling systems, quality systems, safety/pharmacovigilance systems, and enterprise data platforms.
• Exposure to industry tools and platforms such as Veeva Vault RIM, RIMDocs, TrackWise, Sparta, eCTD submission tools, regulatory intelligence tools, workflow tools, reporting platforms, and enterprise integration services.
• Experience with modern technology stacks such as cloud platforms, full-stack web applications, databases, search platforms, workflow engines, DevSecOps pipelines, AWS Services, and monitoring/observability tools.
• Awareness of AI/ML, GenAI, RAG, Agentic AI, document intelligence, natural language processing, and agentic automation use cases in regulatory operations will be an added advantage.

• 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.

• 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.