Title: Veeva Publishing/Submission

Location: Bangalore, Chennai, Mumbai

Exp: 3-6 Years

Job Description:
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 setting.
- Good understanding of 21 CFR Part 11 compliance requirements.
- Strong attention to detail, analytical skills, and communication abilities.

📌 Veeva Publishing/Submission (Mumbai)
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