
Regulatory Publishing Specialist
1 day ago
Job Title: Regulatory Publishing Specialist
Job Description:- Prepare and manage biologics license applications in electronic common technical document 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 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.
- 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.
Benefits: A fulfilling career in regulatory publishing offers numerous benefits, including the opportunity to work on complex projects, develop valuable skills, and contribute to the success of the organization.
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BLA Regulatory Publishing Professional
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