
BLA Regulatory Content Developer – eCTD Publishing Specialist
3 days ago
Job Description
- As a Regulatory Publishing Specialist, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing. This includes compiling, formatting, and publishing regulatory documents according to global health authority requirements.
- You will ensure compliance with regulatory guidelines (FDA, EMA) and internal processes. This involves performing QC of eCTD submissions, including file structure, hyperlinks, and metadata.
- Collaboration with cross-functional teams (Regulatory, Clinical, CMC) is essential to gather and manage content. You will also track submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications
- Strong experience in Veeva Vault eCTD Publishing for BLA submissions is mandatory.
- Knowledge of global regulatory requirements (FDA, EMA) is required.
- Hands-on experience in preparing eCTD sequences and publishing ready dossiers is necessary.
- A strong attention to detail and organizational skills are essential for success in this role.
- Good communication skills to collaborate with multiple stakeholders are required.
- Prior experience in Life Sciences / Pharma regulatory publishing is highly valued.
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