BLA Regulatory Publishing Specialist – Veeva eCTD

Key Responsibilities: Prepare and manageBLA (Biologics License Application)submissions in eCTD format usingVeeva 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: Strong experience inVeeva Vault eCTD Publishingfor 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.

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