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1 week ago
As a Regulatory Publishing Specialist, you will be responsible for preparing and managing Biologics License Application (BLA) submissions in electronic Common Technical Document (eCTD) format using Veeva Vault.
You will compile, format, and publish regulatory documents according to global health authority requirements, ensuring compliance with regulatory guidelines and internal processes.
Additionally, you will perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata, and collaborate with cross-functional teams to gather and manage content.
Required Skills & QualificationsTo succeed in this role, you must have:
- Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
- Knowledge of global regulatory requirements.
- 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.
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