
Senior Regulatory Publishing Coordinator
5 days ago
Job Overview
The Regulatory Publishing Specialist will be responsible for managing and preparing regulatory submissions in electronic format using Veeva Vault eCTD Publishing.
Key Responsibilities:
- Compile, format, and publish regulatory documents according to global health authority requirements.
- Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
- Perform quality control 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.
Requirements:
- Strong experience in Veeva Vault eCTD Publishing for regulatory submissions.
- Knowledge of global regulatory requirements (FDA, EMA).
- Hands-on experience in preparing electronic 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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