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1 week ago
As a skilled Regulatory Publishing Specialist, you will be responsible for preparing and managing Biologics License Application (BLA) submissions in eCTD format using Veeva Vault eCTD Publishing.
The ideal candidate will have prior experience in Life Sciences / Pharma regulatory publishing and be familiar with global regulatory requirements.
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 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.
Required Skills and 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.
This role requires a high degree of accuracy, attention to detail, and strong organizational skills. The ideal candidate will have prior experience in Life Sciences / Pharma regulatory publishing and be familiar with global regulatory requirements.
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