Overview
Remote
On Site
Hybrid
BASED ON EXPERIENCE
Accepts corp to corp applications
Contract - W2
Contract - Independent
Skills
PHARMA
PHARMACY
PHARMACEUTICAL
PHARMACEUTICALS
GENAI
GEN-AI
GEN AI
GENERATIVE
GENERATIVE-AI
REGULATORY
Job Details
- Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance.
- Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases.
- 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).
- 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.
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