Description

Lead the discovery, definition, and rollout of Veeva Regulatory Information Management (RIM) and Clinical Trial Management System (CTMS) solutions.

Responsibilities

• Create detailed functional design architecture and process artifacts for regulatory systems.
• Support system validation as a subject matter expert and lead user acceptance testing.
• Define acceptance criteria and test scenarios based on complex business requirements.
• Facilitate knowledge transfer to deliver consulting solutions for global regulatory needs.

Required Skills

• 5+ years of experience in Veeva Vault, RIM, Reg 1, or CTMS configuration.
• Deep knowledge of regulatory submission processes, product registration, and tracking.
• Experience with EVMPD, IDMP, and Product License Tracking for small molecules, medical devices, or biologics.
• Familiarity with regulatory document management and eCTD/CMC submission authoring and assembly.
• Understanding of FDA and EMA submission requirements and associated regulations.
• Knowledge of labeling processes and systems, including Above Country, In Country, and SPL.
• Proficiency in the Software Development Life Cycle (SDLC).
• Ability to model business processes, data flows, and workflow processes.

Preferred Skills

• Basic knowledge of writing custom SQL or PL/SQL queries for data extraction and validation.
• Strong business analysis skills including requirement elicitation and user story documentation.

Key Skills

Education

Any Graduate