ActiveSoft, Inc
Pharma Global Regulatory Affairs IT Solution Architect - Remote
Remote - Contracted
- 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.
