Executive Director, Regulatory & Medical Tech Strategy

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

Benefits offered by this job

Annual bonuses

Equity awards

Pension benefits

401(k) company match

Health insurance

Wellness programs

Fitness centers

Paid time off

Family support benefits

Job summary

Regeneron seeks an Executive Director, Reg, Medical & CDU Business Solution Lead to orchestrate D&T capabilities for regulatory affairs, medical affairs, and clinical data. Lead a portfolio of platforms (Veeva RIM/Veeva Vault/clinical data tools) and guide Directors to deliver on enterprise objectives.

You will own strategy, governance, and compliant operations across initiatives, partnering with business leaders, IT, and Security to ensure timely, compliant regulatory submissions and medical

Qualifications

• Bachelor's degree required; 15+ years in enterprise-scale regulatory/medical/clinical data tech.
• Masters preferred; biotech/pharma life sciences experience preferred.
• Experience leading Directors/Managers with budget and vendor accountability.
• Strong knowledge of regulatory information management systems and validation practices.

Responsibilities

• Own platform strategy and delivery for regulatory, medical affairs, and clinical data tech portfolios.
• Lead a team of Directors; manage budgets, forecasts, and vendor contracts.
• Ensure compliance with data integrity, validation, and audit readiness for submissions.
• Partner with IT and security to align investments with enterprise standards.

Skills

Leadership

Budget management

Stakeholder management

Strategic thinking

Executive communication

Education

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

Masters degree preferred

Tools

Veeva RIM

Veeva Vault

Medical inquiry/response platforms

Clinical imaging platforms

Job description

Regeneron seeks an Executive Director, Reg, Medical & CDU Business Solution Lead to orchestrate D&T capabilities for regulatory affairs, medical affairs, and clinical data. Lead a portfolio of platforms (Veeva RIM/Veeva Vault/clinical data tools) and guide Directors to deliver on enterprise objectives.

You will own strategy, governance, and compliant operations across initiatives, partnering with business leaders, IT, and Security to ensure timely, compliant regulatory submissions and medical