Regulatory Platform Lead, Veeva RIM & Digital Platform

biomarin; United States; On-site; USD 140,000 - 195,000; Full time

Job summary

BioMarin seeks a Principal Application Lead, Digital Platform - Veeva to own operations, governance, and roadmap execution for Veeva RIM Vault capabilities including submissions, registrations, and publishing. You will partner across Regulatory Affairs, R&D, Quality, and vendors to deliver scalable, validated solutions and drive continuous improvement.

You will lead lifecycle management, validation coordination, and post-release readiness, ensuring change control and audit readiness while

Qualifications

• 8+ years in IT/regulatory tech or related fields.
• 5+ years in full lifecycle, release management, validation of enterprise SaaS apps.
• 4+ years with Regulatory Information Management systems.
• Experience supporting Regulatory Operations processes (planning, publishing, tracking).
• Experience managing roadmaps, governance, vendor delivery, and production support.
• GxP-regulated pharmaceutical/biotech environment experience.
• Proven ability to define requirements, assess fit/gap, and coordinate validation.

Responsibilities

• Provide application leadership and governance for Veeva RIM Vault and related processes.
• Drive regulatory digital roadmap aligned to regulatory strategy and platform scalability.
• Translate regulatory needs into technology capabilities across documents, data, publishing, and submissions.
• Oversee governance forums with Regulatory, R&D, Quality, DTA, and partners.
• Guide lifecycle management including release impact assessments, validation coordination, and post-release readiness.
• Maintain validated state with change control, documentation, and approvals.
• Lead solution delivery including business analysis, configuration, testing, deployment, and support.
• Apply product management and agile delivery practices to backlog shaping and release planning.
• Direct managed service resources and ensure delivery accountability.
• Resolve complex issues with cross-functional teams and vendors.
• Leverage AI tools to improve productivity and compliance activities.

Skills

Leadership

Regulatory knowledge

GxP validation

21 CFR Part 11

AI/Automation

Data governance

Stakeholder management

Vendor management

Product management

Agile delivery

Education

Bachelor's degree or higher in Information Systems/Technology

Veeva Vault certification preferred

Tools

Veeva RIM

Veeva Vault

Job description

BioMarin seeks a Principal Application Lead, Digital Platform - Veeva to own operations, governance, and roadmap execution for Veeva RIM Vault capabilities including submissions, registrations, and publishing. You will partner across Regulatory Affairs, R&D, Quality, and vendors to deliver scalable, validated solutions and drive continuous improvement.

You will lead lifecycle management, validation coordination, and post-release readiness, ensuring change control and audit readiness while