Head of REMS & Patient Safety Strategy

UCB; Atlanta (GA); Hybrid; USD 184,000 - 242,000; Full time

Job summary

UCB in Atlanta seeks a strategic Head of Risk Evaluation & Mitigation Strategies to lead the REMS function and help build a centralized REMS Center of Excellence. This director-level role reports to the Head of Medical and focuses on patient safety, regulatory compliance, and scalable governance.

You will lead two REMS programs, drive cross-functional collaboration, manage vendors and regulatory submissions, and ensure inspections readiness while shaping the future REMS capabilities for the

Qualifications

• Bachelor’s degree in a scientific or technical discipline.
• Minimum of 8 years in pharmaceuticals/biotech with specialized REMS expertise and experience with compliance oversight and program implementation.
• Advanced degree and/or regulatory certification preferred.

Responsibilities

• Lead strategy, implementation, and governance of two REMS programs, ensuring FDA compliance and patient safety.
• Build and oversee a centralized REMS Center of Excellence with scalable operating models and compliance frameworks.
• Drive cross-functional REMS strategy across internal functions and external partners.
• Manage end-to-end REMS operations, including vendors, enrollment, monitoring, reporting, audits, and inspections.
• Lead REMS regulatory submissions, FDA communications, and program modifications.
• Ensure inspection readiness, risk management, compliance monitoring, and continuous improvement.
• Manage program budgets, operational risks, and regulatory commitments.
• Serve as the REMS subject matter expert, leading organizational change, capability building, and stakeholder alignment.

Skills

Leadership

REMS expertise

Cross-functional collaboration

Regulatory oversight

Vendor management

Education

Bachelor’s degree in a scientific or technical discipline

Advanced degree (preferred)

Tools

Regulatory information systems

CAPA management

Job description

UCB in Atlanta seeks a strategic Head of Risk Evaluation & Mitigation Strategies to lead the REMS function and help build a centralized REMS Center of Excellence. This director-level role reports to the Head of Medical and focuses on patient safety, regulatory compliance, and scalable governance.

You will lead two REMS programs, drive cross-functional collaboration, manage vendors and regulatory submissions, and ensure inspections readiness while shaping the future REMS capabilities for the