Description

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

Education

ANY GRADUATE