Description

Lead regulatory affairs strategy and CMC submissions while owning the requirements and validation for the new Regulatory Analytics platform.

This role is on-site.

Responsibilities

• Develop detailed project plans and lead kickoffs with IT, Validation, and Business stakeholders.
• Solicit and document requirements for the Regulatory Analytics platform, including reports, dashboards, and models.
• Conduct impact assessments and provide regular status reporting throughout the project lifecycle.
• Collaborate with squad resources, Product Teams, and Technical Services to support business use cases.
• Maintain all SDLC and validation deliverables within Asset Management and JIRA, including User Stories.

Required Skills

• 10+ years of experience in Global Regulatory affairs and CMC submissions.
• Deep knowledge of Regulatory Analytics platforms.
• Experience with SDLC and validation processes.
• Proficiency in requirement definition for business-prioritized use cases.
• Ability to support test planning and script creation.
• Experience managing documentation within JIRA.
• Background in Regulatory Insights and affairs.

Preferred Skills

• Experience with Veeva systems.

Key Skills

Education

ANY GRADUATE