
Senior Regulatory Publishing Specialist – eCTD Documents
17 hours ago
Job Opportunity:
This role is focused on preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing. You will compile, format, and publish regulatory documents according to global health authority requirements while ensuring compliance with regulatory guidelines.
Key Responsibilities- Prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing software.
- Compile, format, and publish regulatory documents according to global health authority regulations.
- Ensure compliance with regulatory guidelines (FDA, EMA) and internal procedures.
- Perform quality control 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.
- Strong experience in Veeva Vault eCTD Publishing for BLA submissions is essential.
- Knowledge of global regulatory requirements is mandatory.
- Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
- Attention to detail with strong organizational skills is required.
- Good communication skills to collaborate with multiple stakeholders.
- Prior experience in Life Sciences / Pharma regulatory publishing is necessary.
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