Pharma Global Regulatory Affairs IT Solution Architect at Raritan, NJ (Onsite 4-5 days)

Overview

On Site
Accepts corp to corp applications
Contract - Long term

Skills

architect
Data Governance
PHARMA
GXP
Regulatory

Job Details

Title: Role: Pharma Global Regulatory Affairs IT Solution Architect

Location Raritan, NJ (Onsite 4-5 days)

Type: Contract

Responsibilities:

  • Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance.
  • Collaborate with business stakeholders to understand requirements and translate them into scalable, compliant, and efficient technology solutions.
  • Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways.
  • Design and optimize Cloud-native data pipelines for regulatory data ingestion, transformation, and analytics (e.g., using Azure, AWS, or Google Cloud Platform).
  • Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases.
  • Ensure data integrity, GxP compliance, and audit readiness across all regulatory systems and data flows.
  • Evaluate and select technologies and vendors that align with enterprise architecture standards and future vision.
  • Collaborate with QA, validation, and compliance teams to support system validation and lifecycle management under regulatory frameworks.
  • Provide thought leadership on emerging technologies (e.g., AI/ML, LLMs, NLP) and their relevance to the evolving regulatory landscape.
  • Lead or support integration of external partner systems and health authority interfaces (e.g., EMA, FDA, PMDA).
  • Work closely with Data Governance teams to ensure master data and metadata management align with IDMP and xEVMPD standards.
  • Drive the adoption of modern APIs and microservices to support modular, reusable architectures.
  • Contribute to or lead architectural reviews, risk assessments, and remediation planning.
  • Provide mentorship and technical guidance to development and support teams.
  • Exposure to DevOps pipelines and practices (CI/CD, containerization, IaC) is a plus.
  • 8+ years of experience in pharma or life sciences IT, with at least 3+ years in Regulatory Affairs systems.
  • Proven experience in designing enterprise-scale IT architectures using cloud platforms.
  • Hands-on experience with GenAI or NLP technologies applied in the pharma or healthcare context.
  • Strong understanding of regulatory standards and systems (e.g., Veeva Vault RIM, IDMP, eCTD).
  • Excellent communication, stakeholder engagement, and cross-functional leadership skills.

Thanks & Regards

Ash Kumar

Client Engagement Partner

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"Disclaimer: E-Solutions Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation,gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability."


Pharma Global Regulatory Affairs IT Solution Architect1architect,Data Governance,PHARMA,GXP,RegulatoryN/AC2CUnited States
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