Executive Director – Regulatory, Medical, CDU Solutions Partner

Regeneron

. Serve as the key interface between business leadership and Digital & Technology for Regulatory Affairs, Medical Affairs, and Clinical Data functions .

Posted 10/6/2026full-timeTarrytown • New York • United StatesSeniorLead💰 $255,000 - $424,900 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing enterprise-scale regulatory, medical affairs, and clinical data technology platforms, with a strong focus on budget management, vendor contracts, and compliance with GxP validation practices. Proven ability to lead multi-disciplinary teams and align technology strategies with business objectives.

Highest-signal resume keywords

Regulatory Information ManagementMedical Affairs SystemsBudget ManagementStakeholder ManagementTeam Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Information ManagementClinical Data ManagementGxP Validation PracticesSolution Delivery Life Cycle ManagementPlatform Strategy DevelopmentIncident ManagementRelease GovernanceVendor ManagementTechnology Capability IdentificationOrganizational Design

Soft Skills

Executive CommunicationStakeholder EngagementTeam MotivationNegotiation SkillsCoaching and Development

Tools & Technologies

Veeva RIMVeeva VaultMediverseIEnvisionPrecision Medicine PlatformsClinical Imaging PlatformsDigital Medicine Platforms

Certifications & Qualifications

PMPITILSAFe Agile

Industry Keywords

BiotechPharmaLife SciencesRegulatory ComplianceMedical Inquiry

Tech Stack

Tools & technologies

PMPVault

About the role

Key responsibilities & impact

Serve as the key interface between business leadership and Digital & Technology for Regulatory Affairs, Medical Affairs, and Clinical Data functions
Own the technology roadmap and strategy across platforms including Veeva RIM, Mediverse, iEnvision, Precision Medicine, Clinical Imaging, and Digital Medicine platforms
Lead a team of Directors delivering platform strategy, delivery governance, and compliant operations
Partner with senior business leadership to align technology capabilities with enterprise objectives
Translate business priorities into a funded, prioritized multi-year delivery plan
Own organizational design, structure, role allocation, and resourcing for the Business Solution function
Establish governance frameworks, standards, and validation practices
Own budget, forecasts, vendor contracts, software licensing, and services agreements
Oversee planning, prioritization, execution, product backlogs, incident management, and release governance
Coach and develop Directors and Managers
Manage steering committee meetings, working groups, and issue/release management
Ensure platforms meet validation, data integrity, audit-readiness, and regulatory compliance standards
Oversee regulatory information management, medical inquiry, and clinical data workflows
Partner with Enterprise IT, Enterprise Architecture, Information Security, Regulatory Affairs, Medical Affairs, Quality, and vendors
Represent technology priorities in enterprise architecture and governance forums
Engage senior stakeholders on complex or ambiguous issues
Monitor industry trends and present innovative approaches to senior leadership
Prepare and deliver executive-level materials on platform portfolio health and roadmap

Requirements

What you’ll need

Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field
15+ years of progressive industry/relevant professional experience
Significant experience managing enterprise-scale regulatory, medical affairs, or clinical data technology platforms
Experience in the biotech, pharma, or life sciences industry strongly preferred
Experience leading a multi-disciplinary team of Directors and Managers
Budget and vendor contract accountability for a major function
Deep expertise in regulatory information management and medical affairs systems, such as Veeva RIM, Veeva Vault, and medical inquiry/response platforms
Experience with clinical data and precision medicine technology, including 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
Proven budget and vendor management experience
Strong stakeholder management and negotiation skills
Ability to grow, motivate, and develop teams
Ability to define organizational structure and set long-term goals and objectives
Exceptional executive communication skills
PMP or equivalent project/program management certification preferred
ITIL or SAFe Agile certification preferred

Benefits

Comp & perks

Annual bonuses or other incentive plans
Equity awards
Pension or retirement benefits
401(k) company match
Health and wellness programs
Fitness centers
Medical, dental, vision, life, and disability insurance benefits
Paid time off
Family support benefits
Reasonable accommodation during the recruitment process where required