
Regulatory Document Specialist
2 weeks ago
Key Responsibilities:
- Prepare and manage Biologics License Application (BLA) submissions in electronic Common Technical Document (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 & 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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