Veeva Publishing/Submission

Key Responsibilities-

• Publish regulatory submissions using Veeva Vault RIM and related Veeva Vault applications.
• Support document preparation, formatting, hyperlinking, bookmarking, and validation for regulatory submissions such as IND, NDA, CTA, and MAA.
• Ensure submission packages comply with applicable eCTD standards and global regulatory requirements.
• Collaborate with Regulatory Affairs, Regulatory Operations, and Document Management teams to ensure submission readiness.
• Maintain submission trackers, timelines, and communication logs within Veeva.
• Provide technical support for Veeva Vault publishing tools and workflows.
• Troubleshoot publishing-related issues and coordinate with relevant teams for resolution.
• Participate in publishing process improvements and optimization initiatives.
• Ensure adherence to SOPs, GxP guidelines, and regulatory compliance requirements.

Required Skills & Experience

• Hands-on experience with Veeva Vault RIM or Veeva Vault Submissions is required.
• Relevant certification in Veeva Vault RIM or Veeva Vault Submissions is preferred/required as applicable.
• Strong understanding of regulatory submission publishing and eCTD requirements.
• Knowledge of the submission lifecycle from document authoring through publishing and archival.
• Familiarity with global health authority submission portals such as ESG and EMA Gateway.
• Experience working in a GxP-regulated environment.
• Good understanding of 21 CFR Part 11 compliance requirements.
• Strong attention to detail, analytical skills, and communication abilities.