Head of REMS US, Atlanta, GA

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

Make your mark for patients

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.

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.

About Us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

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.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail] for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.