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4 days ago
Job Title: Regulatory Publishing Professional for eCTD Document Management
We are seeking a skilled Regulatory Publishing Professional to join our team. The successful candidate will be responsible for preparing and managing Biologics License Application (BLA) submissions in eCTD format using Veeva Vault eCTD Publishing.
Key Responsibilities:- Compile, format, and publish regulatory documents according to global health authority requirements.
- Evaluate submission content for compliance with regulatory guidelines and internal processes.
- Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
- Collaborate with cross-functional teams to gather and manage content.
- Track submission timelines and deliverables to meet regulatory deadlines.
- Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
- Demonstrated 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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