
Regulatory Publishing Expert
1 week ago
As a Regulatory Publishing Specialist, you will play a pivotal role in preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
- Key Responsibilities:
- Compile and format regulatory documents according to global health authority requirements.
- Perform Quality Control (QC) 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.
- 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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