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.
About the role 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.
Who you'll work with You'll collaborate with internal teams involved in and impacted by REMS, including Regulatory Affairs, Medical Affairs, Pharmacovigilance, Patient Safety, Quality, Patient Services, Data, Market Access, Commercial, Supply Chain, and Legal. You'll also partner with external vendors and other partners supporting REMS setup, administration, monitoring, and reporting.
What you'll do - 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.
Interested? For this role we're looking for the following education, experience and skills Minimum 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.
Preferred Qualifications - 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.
This position's reasonably anticipated salary range is $184,000-$242,000 per year. The actual salary offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience, among other factors.
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.
