
Regulatory Publishing Specialist
3 days ago
Responsibilities:
- Prepare and manage BLA submissions in eCTD format using Veeva Vault.
- 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.
Key Requirements:
- 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.
A dynamic and supportive work environment that fosters growth and collaboration.
Opportunities to develop your skills and expertise in a rapidly evolving field.
Professional development programs to support your career advancement.
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