Ex Dir Regulatory, Medical, & CDU Solutions Partner

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.

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 Partnership

• Partner with Enterprise IT, Enterprise Architecture, and Information Security to align platform investments with enterprise standards and security requirements.
• Build and maintain relationships with key platform vendors to clarify demands, resolve conflicts, and align technology roadmaps to business needs.
• Represent Reg, Medical & CDU technology priorities in enterprise architecture and governance forums, ensuring alignment with enterprise-wide standards.

Executive & Stakeholder Engagement

• Serve as the primary point of contact for senior Regulatory Affairs, Medical Affairs, and Clinical Development leadership on matters requiring negotiation of complex or ambiguous issues.
• Build relationships with key business leaders to clarify demands, resolve conflicts, and align technology roadmaps with regulatory and medical affairs priorities.
• Monitor industry trends in regulatory information management, medical affairs technology, and clinical data platforms, bringing forward innovative approaches to senior leadership.
• Prepare and deliver executive-level materials on the health and roadmap of the platform portfolio for governance forums and senior leadership.

Qualifications and Requirements

Education & Experience

• Bachelor's degree in Computer Science, Information Systems, Business Administration, or a related field (Master's degree preferred).
• 15+ years of progressive industry/relevant professional experience, including significant experience managing enterprise-scale regulatory, medical affairs, or clinical data technology platforms.
• Experience in the biotech, pharma, or life sciences industry strongly preferred.
• Proven experience leading a multi-disciplinary team of Directors and Managers, including budget and vendor contract accountability for a major function.

Technical Expertise

• Deep expertise in regulatory information management and medical affairs systems (e.g., Veeva RIM, Veeva Vault, medical inquiry/response platforms).
• Experience with clinical data and precision medicine technology (e.g., clinical imaging and digital medicine platforms).
• Strong knowledge of GxP validation practices and solution delivery life cycle management.
• Experience managing technology capability identification, selection, and implementation across multiple simultaneous platform initiatives.

Skills & Competencies

• Proven track record of budget and vendor management for a department or major function.
• Strong stakeholder management and negotiation skills, with experience influencing senior management internally and externally.
• Demonstrated ability to grow, motivate, and develop teams, coaching Directors and Managers through career milestones and progression.
• Strategic mindset with the ability to define organizational structure and set long-term goals and objectives for a major function.
• Exceptional executive communication skills, with experience engaging senior/executive leadership on sensitive or ambiguous matters.

Certifications (Preferred)

• PMP or equivalent project/program management certification.
• ITIL or SAFe Agile certification.