Pharma Regulatory domain Solution Architect

• Title - Solution Architect with strong Pharma Regulatory domain expertise
• Location Raritan, New Jersey
• Work Mode Hybrid (the candidate shall be required to work from client's office for 3 4 days in a week)
• Start ASAP
• Cost DOE
• Resource Type open for both FTE + Subcons

Please check the JD below and ensure that the candidates that are submitted have strong experience with Pharma Regulatory domain and are from the same background.

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.

• 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, Track Wise, Sparta, eCTD submission tools, regulatory intelligence tools, workflow tools, reporting platforms, and enterprise integration services.