BLA Regulatory Publishing Specialist – Veeva eCTD
3 weeks ago
Key Responsibilities:Prepare and manageBLA (Biologics License Application)submissions in eCTD format usingVeeva 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 inVeeva Vault eCTD Publishingfor 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.
-
Delhi, India vueverse. Full timeKey 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,...
-
Regulatory Submission Publisher
5 days ago
New Delhi, India Aurolab Full timePurpose: Regulatory Submission Publisher will be responsible for assisting in the compilation, formatting, publishing, and validation of regulatory submissions in eCTD and non-eCTD formats. The role will provide exposure to global regulatory submission requirements for agencies such as US FDA, EMA, Health Canada, MHRA, and others.Responsibilities:- •...
-
Configuration Specialist
2 weeks ago
Delhi, India vueverse. Full timeOBJECTIVEThe 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, and...
-
Configuration specialist
2 weeks ago
Delhi, India Vueverse. Full timeOBJECTIVEThe 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, and...
-
Configuration specialist
1 week ago
Delhi, India Vueverse. Full timeOBJECTIVEThe 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, and...
-
Configuration Specialist
5 days ago
Delhi, India vueverse. Full timeOBJECTIVEThe 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, and...
-
Configuration Specialist
4 weeks ago
Delhi, India vueverse. Full timeOBJECTIVEThe 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, and...
-
Veeva Developer
2 weeks ago
Delhi, India RandomTrees Full timeRandomTrees is a leading Data & AI company offering a diverse range of products and services within the data and AI space. We are seeking a skilled eQMS - Veeva Developer. We support multiple industries, including Pharma, Banking, Semiconductor, Oil & Gas, and more. Additionally, we are actively engaged in research and innovation in Generative AI (GenAI) and...
-
Veeva Developer
2 weeks ago
Delhi, India RandomTrees Full timeRandomTrees is a leading Data & AI company offering a diverse range of products and services within the data and AI space. We are seeking a skilled eQMS - Veeva Developer. We support multiple industries, including Pharma, Banking, Semiconductor, Oil & Gas, and more. Additionally, we are actively engaged in research and innovation in Generative AI (GenAI) and...
-
Configuration Specialist
1 week ago
New Delhi, India vueverse. Full timeOBJECTIVEThe 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, and...
