Solution Architect strong Pharma Regulatory domain expertise

Solution Architect with strong Pharma Regulatory domain expertise

Job Title: Solution Architect - Pharma Regulatory Location: New Jersey, Hybrid (3-4 days in office)

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 into scalable technology solutions, and present a clear point of view to stakeholders. This role 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.

• 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 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.
• 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, 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.

• 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, Track Wise, 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, Dev Sec Ops  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…