Remote Associate Manager, AI Safety Data & Systems

Regulatory Jobs; North Carolina; Remote; USD 110,000 - 170,000; Full time

Job summary

Regulatory Jobs seeks an experienced AI/ML/NLP engineer to design, validate and maintain safety data systems in a GxP-regulated environment. You will develop AI/ML components for MedDRA/WHODrug auto-coding, case triage and narrative summarization with human-in-the-loop checkpoints, and work closely with QA, DT/BIS and GPS Signal Management.

Your responsibilities include model lifecycle management, risk-based validation, regulatory alignment with EMA/FDA guidelines, and hands-on configuration of

Qualifications

• Bachelor's degree in CS, data science, computational linguistics, or related field required.
• Experience with Python, ML/NLP frameworks, model deployment/monitoring, and MLOps tooling; exposure to LLMs preferred.
• Familiarity with GVP/21 CFR concepts is a plus; knowledge of Argus/ArisG data models beneficial.

Responsibilities

• Design, develop and validate AI/ML/NLP components for safety operations with human-in-the-loop checkpoints.
• Lead model lifecycle management and governance in line with DT/BIS standards.
• Collaborate with Quality, DT/BIS, GPS Signal Management and regulatory teams to ensure compliance.

Skills

Python

NLP

ML frameworks

Transformers

Model evaluation

Education

Bachelor's degree in CS / related field

Tools

ARGUS/ArisG

E2B(R3)

MLflow

Azure ML

Job description

Regulatory Jobs seeks an experienced AI/ML/NLP engineer to design, validate and maintain safety data systems in a GxP-regulated environment. You will develop AI/ML components for MedDRA/WHODrug auto-coding, case triage and narrative summarization with human-in-the-loop checkpoints, and work closely with QA, DT/BIS and GPS Signal Management.

Your responsibilities include model lifecycle management, risk-based validation, regulatory alignment with EMA/FDA guidelines, and hands-on configuration of