Associate Director, Global Patient Safety Standards & Training

Regeneron seeks an Associate Director to establish and maintain pharmacovigilance procedures and policies aligned with global regulatory requirements. The role ensures the PV system remains compliant, audit-ready, and operationally effective while supporting training and process optimization initiatives.

Responsibilities

• Assess PV intelligence updates and align GPS procedures with evolving regulatory expectations
• Liaise with Process & Procedures and Learning Centre teams to ensure procedural changes accurately reflect in training
• Develop and maintain pharmacovigilance procedures using PV expertise and regulatory alignment
• Manage process deviations, CAPAs, and training compliance metrics for GPS leadership
• Represent Standards & Training in regulatory audits and inspections

Requirements

• Bachelor's degree minimum; life sciences education strongly preferred
• 7+ years pharmacovigilance, drug safety, regulatory affairs, or quality assurance experience
• Deep knowledge of PV regulations and quality management systems
• Proven experience managing procedural updates and process design
• Strong document writing skills meeting procedural quality standards
• Project management experience with document control systems
• Audit and inspection presentation experience