Associate Director, Regulated Biotech IT

Regeneron Pharmaceuticals; Warren (MI); Hybrid; USD 157,000 - 257,000; Full time

Job summary

Regeneron Pharmaceuticals seeks an Associate Director, Product Lead to guide GD IT delivery across protocol digitization, DDF, and biospecimen lifecycle management. Based in Warren, NJ, the role emphasizes end-to-end ownership, governance, and collaboration with BSPs, SMEs, and vendors.

On-site expectations are four days per week with hybrid work patterns. You will coach senior teams, shape roadmaps, and drive continuous improvement in a regulatory, GxP environment supporting 21 CFR Part

Qualifications

• Strong knowledge of SDLC and ITIL frameworks.
• Experience interacting with senior leadership and executives.
• Experience applying AI governance and regulated AI in GxP contexts.

Responsibilities

• Lead and develop a team of Product Leads and Product Analysts across multiple domains.
• Own domain strategy, roadmap, and governance for protocol digitization and biospecimen workflows.
• Manage multi-product portfolio, vendor governance, and regulatory compliance.

Skills

Leadership

Stakeholder management

Communication skills

Agile

AI governance

Project management

Budget management

SDLC/ITIL knowledge

Tools

Nurocor

USDM/ICH M11 tools

LIMS/LIS

EDC

CTMS

APIs (REST/GraphQL)

Job description

Regeneron Pharmaceuticals seeks an Associate Director, Product Lead to guide GD IT delivery across protocol digitization, DDF, and biospecimen lifecycle management. Based in Warren, NJ, the role emphasizes end-to-end ownership, governance, and collaboration with BSPs, SMEs, and vendors.

On-site expectations are four days per week with hybrid work patterns. You will coach senior teams, shape roadmaps, and drive continuous improvement in a regulatory, GxP environment supporting 21 CFR Part