(Urgent) BLA Regulatory Publishing Specialist – Veeva eCTD

6 days ago


India vueverse. Full time

Key Responsibilities:

- Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.
- Compile, format, and publish regulatory documents according to global health authority requirements.
- Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
- Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
- Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
- Track submission timelines and deliverables to meet regulatory deadlines.

Required Skills & Qualifications:

- Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
- Knowledge of global regulatory requirements (FDA, EMA).
- Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
- Attention to detail with strong organizational skills.
- Good communication skills to collaborate with multiple stakeholders.
- Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.



  • India vueverse. Full time

    Key Responsibilities: Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing . Compile, format, and publish regulatory documents according to global health authority requirements. Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes. Perform QC of eCTD submissions,...


  • India vueverse. Full time

    Key Responsibilities: Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing . Compile, format, and publish regulatory documents according to global health authority requirements. Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes. Perform QC of eCTD...


  • India vueverse. Full time

    Key Responsibilities:Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.Compile, format, and publish regulatory documents according to global health authority requirements.Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.Perform QC of eCTD submissions, including...


  • India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000

    Key Responsibilities:Manage BLA submissions in eCTD format using Veeva Vault.Compile, format, and publish regulatory documents according to global health authority requirements.Ensure compliance with regulatory guidelines and internal processes.Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.Collaborate with...


  • India Zensar Full time

    Job Title Veeva RIM Migration Lead 8-12 - CTC - Location Specify Location or Remote Department Regulatory Operations IT Transformation Reports To Program Manager Director of Regulatory Systems Role Overview The Veeva RIM Smart Migration Lead is responsible for planning executing and overseeing the migration of regulatory data and...


  • India Zensar Technologies Full time ₹ 15,00,000 - ₹ 28,00,000 per year

    Job Title: Veeva RIM Migration Lead – CTC -Location: [Specify Location or Remote]Department: Regulatory Operations / IT / TransformationReports To: Program Manager / Director of Regulatory SystemsRole Overview:The Veeva RIM Smart Migration Lead is responsible for planning, executing, and overseeing the migration of regulatory data and documents from legacy...


  • India Zensar Technologies Full time

    Job Title: Veeva RIM Migration Lead – CTC - Location: (Specify Location or Remote) Department: Regulatory Operations / IT / Transformation Reports To: Program Manager / Director of Regulatory Systems Role Overview: The Veeva RIM Smart Migration Lead is responsible for planning, executing, and overseeing the migration of regulatory data and documents from...


  • India Vueverse. Full time

    OBJECTIVE The role of Veeva Vault Technical Support is responsible for providing expert-level support and administration for Veeva Vault applications. This includes troubleshooting system issues, assisting users, managing configurations, and ensuring optimal performance of the platform. The specialist will collaborate with internal teams, business users,...


  • India vueverse. Full time

    OBJECTIVE The role of Veeva Vault Technical Support is responsible for providing expert-level support and administration for Veeva Vault applications. This includes troubleshooting system issues, assisting users, managing configurations, and ensuring optimal performance of the platform. The specialist will collaborate with internal teams, business users,...


  • India beBeeRegulatory Full time ₹ 12,00,000 - ₹ 20,00,000

    Job Overview:We are seeking a skilled Regulatory Compliance Specialist to support end-to-end submissions for global markets. Required experience includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key ResponsibilitiesVariation Documents and CMC Changes: Prepare Variation documents and/or evaluate post-approval...