Head of REMS US, Atlanta, GA
About The Position
We are seeking an innovative, strategic, and highly influential leader to serve as our Head of Risk Evaluation & Mitigation Strategies (REMS) and help build the foundation of our newly established, centralized REMS Group. This position is based in our Atlanta, GA headquarters. This is a unique opportunity to lead a high-impact function at the forefront of risk management, bringing together cross-functional teams to drive best-in-class REMS strategy and execution across the organization. As a director-level leader reporting to the Head of Medical, you will play a critical role in advancing patient safety, ensuring regulatory compliance, and shaping the future direction of our REMS capabilities.
Requirements
- 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.
Nice To Haves
- Advanced degree and/or relevant regulatory certification.
- Deep expertise in FDA REMS requirements, program launches, implementation, risk management, compliance oversight, and SOP execution.
- Experience working with health authorities, regulatory submissions, pharmacovigilance, audits, inspections, CAPA management, and FDA REMS inspection readiness.
- Proven success establishing and leading REMS Centers of Excellence, integrating multiple programs into scalable operating models with effective governance, policies, procedures, KPIs, and compliance frameworks.
- Strong leadership experience building high-performing teams, mentoring talent, developing organizational capabilities, and driving change within complex matrix environments.
- Demonstrated ability to lead cross-functional collaboration across Regulatory Affairs, Medical Affairs, Pharmacovigilance, Patient Safety, Quality, Commercial, Market Access, Patient Services, Supply Chain, Legal, Data, and external partners.
- Strategic subject matter expertise in FDA interactions, vendor oversight, risk management, audit and inspection readiness, and continuous process improvement.
- Ability to influence and align diverse internal and external stakeholders without direct authority while balancing patient safety, regulatory compliance, operational excellence, and business priorities.
- Experience leveraging digital tools, regulatory information systems, and process innovation to improve efficiency, scalability, and compliance.
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.
Benefits
- UCB is an equal opportunity employer.
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What This Job Offers
Job Type
Full-time
Career Level
Director
