Ex Dir Regulatory, Medical, & CDU Solutions Partner

BioSpace; New Jersey; On-site; USD 255,000 - 425,000; Full time

Job summary

Regeneron is seeking an Executive Director, Reg, Medical & CDU Business Solution Lead to align technology with enterprise objectives across Regulatory Affairs, Medical Affairs, and Clinical Data. The role owns the domain technology roadmap and leads Directors and Managers to deliver governed, compliant platform solutions.

The position partners with Regulatory Affairs, Medical Affairs, Clinical Development, and Enterprise IT to ensure timely, compliant submissions and data integrity across

Qualifications

• Experience leading enterprise-scale regulatory or medical data platforms.
• Proven budget and vendor accountability.
• Strong governance and strategy skills.
• Biotech/pharma experience preferred.

Responsibilities

• Own and execute multi-year platform strategy and roadmap.
• Lead organizational design and resourcing for the Reg, Medical & CDU Business Solution function.
• Oversee budgeting, forecasting, and vendor contracts for the domain.
• Ensure regulatory, medical affairs, and clinical data platforms meet validation and data integrity standards.
• Present executive-level updates on portfolio health and delivery.

Skills

Veeva RIM

Platform governance

Budget management

Stakeholder management

Executive communication

Vendor management

Education

Bachelor's degree in Computer Science, Information Systems, Business Administration, or related field

Job description

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

• 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.
• 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.
• 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.
• 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.
• 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

• Bachelors degree in Computer Science, Information Systems, Business Administration, or a related field (Masters 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.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$255,000.00 - $424,900.00

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.