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2 days ago
We are seeking a highly skilled Regulatory Publishing Specialist eCTD Expert to join our team. As a key member of our regulatory publishing group, you will be responsible for preparing and managing BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.
Key Responsibilities:- Compile, format, and publish regulatory documents according to global health authority requirements.
- Evaluate 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.
- Proficiency in Veeva Vault eCTD Publishing.
- Expertise in global regulatory requirements (FDA, EMA).
- Ability to prepare and publish regulatory documents.
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