Pharma Global Regulatory Affairs IT Solution Architect - Remote

ActiveSoft, Inc; Jersey City (NJ); Remote; USD 120,000 - 180,000; Full time

Job summary

A leading company in the life sciences sector is seeking an experienced IT Architect to design and implement innovative regulatory affairs solutions. The successful candidate will oversee the architectural governance of various regulatory systems and collaborate closely with business stakeholders to ensure compliance and efficiency. This role requires substantial experience in cloud-based IT architecture, regulatory systems, and advanced AI technologies, offering a unique opportunity to influence the future of regulatory operations.

Qualifications

• 8+ years of experience in pharma or life sciences IT.
• 3+ years in Regulatory Affairs systems.
• Proven experience with enterprise-scale IT architectures.

Responsibilities

• Architect and design IT solutions for Regulatory Affairs functions.
• Collaborate with stakeholders to develop scalable technology solutions.
• Lead governance for regulatory systems and cloud-native data pipelines.

Skills

Cloud architecture design

GenAI

NLP technologies

Regulatory standards understanding

Cross-functional leadership

Job description

• 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 GCP).
• 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.