BLA Regulatory Publishing Specialist – Veeva eCTD

Key Responsibilities :

• Prepare and manage BLA (Biologics License Application) 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 (FDA, EMA) and internal processes.
• Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
• Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
• Track submission timelines and deliverables to meet regulatory deadlines.

Required Skills & Qualifications :