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BLA Regulatory Publishing Specialist – Veeva eCTD
vueverse.Kozhikode, IN19 days ago
Job descriptionStrong experience in Veeva Vault eCTD Publishing for BLA submissions. Knowledge of global regulatory requirements (FDA, EMA). 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.
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 :
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Specialist • Kozhikode, IN