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.
Job Description: Solution Architect Pharma
Regulatory
Location: New Jersey, USA, minimum 3 4 days work from office
Role Type: Solution Architecture / Regulatory Technology
Domain: Pharma Regulatory Affairs
Role Overview
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.
Key Responsibilities
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.
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.
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