
Regulatory Publishing Expert for eCTD Submissions
4 days ago
Our ideal candidate is a highly skilled Regulatory Publishing Expert with extensive experience in managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
Key Responsibilities:
- eCTD Submission Management: Prepare, compile, and publish regulatory documents according to global health authority requirements.
- Regulatory Compliance: Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
- Document Quality Control: Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
- Cross-Functional Collaboration: Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
- Project Management: Track submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
- Veeva Vault Experience: Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
- Regulatory Knowledge: Knowledge of global regulatory requirements (FDA, EMA).
- eCTD Sequencing: Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
- Attention to Detail: Attention to detail with strong organizational skills.
- Communication Skills: Good communication skills to collaborate with multiple stakeholders.
- Life Sciences Background: Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.
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