Regulatory SME with Veeva

Job Description

• 10+ years' experience in Global Regulatory affairs, CMC submissions.
• Knowledge on Insights and regulatory affairs.
• Develop the detailed project plan
• Kickoff the project with full project team including IT, Validation and Business participants
• Collaborate with multiple squad resources, and other Product Teams and Technical Services (as needed)
• Conduct the impact assessment
• Provide status reporting for the duration of the project
• Solicit and document requirements for the new Regulatory Analytics platform
• Solicit and document requirements for the new Regulatory Analytics reports, dashboards, and models
• Support requirement definition for experiments from business prioritized use cases
• Ensure update of all SDLC/validation deliverables in Asset Management and JIRA including User Stories
• Support test planning/script creation as needed