Ex Dir Regulatory, Medical CDU Solutions Partner

Position: Ex Dir Regulatory, Medical, & CDU Solutions Partner
The Executive Director, Reg, Medical & CDU Business Solution Lead will serve as the key interface between business leadership and Digital & Technology for Regeneron's Regulatory Affairs, Medical Affairs, and Clinical Data functions, orchestrating D&T capabilities to deliver on business objectives and priorities across platforms including Veeva RIM, Mediverse, iEnvision, and the platforms supporting Precision Medicine, Clinical Imaging, and Digital Medicine.

This role owns the technology roadmap and strategy for the domain, prioritizing investment in partnership with the business and will lead a team of Directors delivering platform strategy, delivery governance, and compliant operations across the regulatory, medical affairs, and clinical data technology portfolio. The Business Solution Lead will partner closely with Regulatory Affairs, Medical Affairs, and Clinical Development business leadership, Enterprise IT, and Information Security to ensure these systems support Regeneron's regulatory submission, medical information, and clinical data obligations.

This role reports to the Executive Director, Global Development IT and will collaborate closely with Regulatory Affairs, Medical Affairs, and Clinical Development leadership to shape the technology roadmap and ensure delivery excellence across the platform portfolio.

Key Responsibilities In this role, you will own platform strategy and delivery for Regeneron's Regulatory Affairs, Medical Affairs, and Clinical Data technology portfolio, leading a team of Directors across the domain. Your day-to-day responsibilities will include:

Reg, Medical & CDU Strategy & Ownership Partner with senior Regulatory Affairs, Medical Affairs, and Clinical Development leadership to align technology and capabilities to deliver on enterprise objectives and priorities.

Own and prioritize, in partnership with the business, the multi-year platform strategy and roadmap, translating regulatory, medical affairs, and clinical data priorities into a funded, prioritized delivery plan.

Own the organizational design of the Reg, Medical & CDU Business Solution function, including structure, role allocation, and resourcing across Directors and Managers assigned to the domain.

Establish governance frameworks, standards, and validation practices for platform delivery, ensuring consistency across teams and vendor engagements.

Own budget, forecast, and vendor contract accountability for the domain's platform portfolio, including software licensing and services agreements.

Delivery Oversight & Team Leadership Serve as the escalation and quality-assurance point for planning, prioritization, and execution of platform initiatives led by reporting Directors.

Oversee product backlog, incident management, and release governance across the domain's platform portfolio, ensuring consistent reporting of value delivered against plan.

Coach and develop Directors and Managers, ensuring delivery commitments are met and domain capabilities continue to mature.

Manage steering committee meetings, working groups, and issue/release management for upgrades to existing platforms.

Regulatory & Medical Compliance Partner with Regulatory Affairs, Medical Affairs, and Quality organizations to ensure platforms meet validation, data integrity, and audit-readiness standards for regulatory submissions and medical information.

Own data classification, access, and quality standards for regulatory, medical affairs, and clinical data, ensuring compliance with global submission and reporting obligations (e.g., FDA, EMA).Maintain oversight of regulatory information management, medical inquiry, and clinical data workflows to ensure platforms support timely and accurate business outcomes.

Cross-Functional & Vendor…