Publishing Compliance Specialist

9 hours ago


Mysore, Karnataka, India beBeeRegulatory Full time ₹ 75,00,000 - ₹ 1,25,00,000

Job Description

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The Regulatory Publishing Specialist will be responsible for preparing and managing submissions in eCTD format using Veeva Vault eCTD Publishing. This includes compiling, formatting, and publishing regulatory documents according to global health authority requirements.

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Key Responsibilities:

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  • 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 to gather and manage content.">
  • Track submission timelines and deliverables to meet regulatory deadlines.">
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Requirements:

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  • Strong experience in Veeva Vault eCTD Publishing for BLA submissions.">
  • Knowledge of global regulatory requirements.">
  • 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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