BLA Regulatory Publishing Professional
24 hours ago
Regulatory Publishing Specialist – eCTD Expert
We are seeking a skilled Regulatory Publishing Specialist to lead our BLA submissions in eCTD format using Veeva Vault eCTD Publishing. The ideal candidate will have extensive experience in global regulatory requirements and compliance.
Key Responsibilities:
- Prepare and manage BLA 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 and internal processes.
- Perform 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.
Required Skills & Qualifications:
- 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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