Solution Architect with strong Pharma Regulatory domain expertise

Role : Solution Architect with strong Pharma Regulatory domain expertise

Location : Raritan, NJ (Hybrid)

Type : Full-Time / Contract

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.

Tools, Applications, and Technology Ecosystem Knowledge

• 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.

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.

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.

Tekshapers is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.