Director, Regulatory and Safety Sciences Technology
Core
Lead technology strategy and platform delivery for Regulatory Affairs, Safety, and Medical Writing to ensure compliant, efficient, and insight-driven regulatory operations across the product lifecycle.
Role type
Director, Regulatory Sciences Technology (Strategic IC with architectural leadership)
Builds
Regulatory information management systems, safety databases, document and submission platforms
Domain
Life Sciences / Biopharma / Regulatory Technology
Deliverable
production ML models | product features | infrastructure
Required skills
GxP-regulated technology platform delivery, data integration, architecture evaluation, vendor management, validation approaches, requirements gathering, project management, root cause analysis, technical troubleshooting
Preferred skills
Regulatory Affairs, Safety, or Medical Writing domain experience, familiarity with RIM and enterprise data ecosystems
Technologies
RIM, safety databases, document/submission platforms
Responsibilities
Serve as primary technology leader and business partner for Regulatory Sciences; develop expertise in business processes to identify automation opportunities; lead delivery and continuous improvement of technology platforms; drive adoption of the technology operating model; oversee solution lifecycle from requirements to support; establish technology governance and compliance standards; provide technical leadership in data and content architecture design; collaborate cross-functionally with Clinical, Medical, Quality, and Commercial teams; manage external vendors and guide application support teams.
Seniority
Director, strategic leadership with hands-on architectural guidance