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2 weeks ago
We are seeking a skilled Regulatory Publishing Specialist to join our team.
About the Role:This is an exciting opportunity to work with BLA submissions in eCTD format using Veeva Vault eCTD Publishing. As a Regulatory Publishing Specialist, you will be responsible for preparing and managing regulatory documents according to global health authority requirements.
- Main Responsibilities:
- Compile, format, and publish regulatory documents according to global health authority requirements.
- Evaluate and ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
- Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
- Required Skills & Qualifications:
- Proven experience in Veeva Vault eCTD Publishing for BLA submissions.
- Knowledge of global regulatory requirements (FDA, EMA).
- 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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