
Senior Regulatory Publishing Professional
2 days ago
Job Description:
The Regulatory Publishing Specialist will be responsible for preparing and managing Biologics License Application (BLA) submissions in electronic Common Technical Document (eCTD) format using Veeva Vault eCTD Publishing.
Key Responsibilities:
- Prepare and manage BLA submissions in eCTD 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 (QC) 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 BLA submissions is required.
- Knowledge of global regulatory requirements is necessary.
- Hands-on experience in preparing eCTD sequences and publishing ready dossiers is mandatory.
- Attention to detail with strong organizational skills is essential.
- Good communication skills are necessary to collaborate with multiple stakeholders.
- Prior experience in Life Sciences/pharmaceutical regulatory publishing is required.
Structure of the Job:
- Summarize the job description in 50 words: The Regulatory Publishing Specialist prepares and manages BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
- Provide a detailed job description as above.
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