Life Science Regulatory Publishing Specialist

5 days ago

Mangalore, Karnataka, India beBeeVeeva Full time ₹ 90,00,000 - ₹ 1,20,00,000

Regulatory Publishing Specialist Role Overview

The role involves preparing and managing regulatory documents in eCTD format for submission to global health authorities. This requires strong experience in Veeva Vault eCTD Publishing and a thorough understanding of regulatory guidelines.

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  • Prepare and manage BLA 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 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.

Required Skills & Qualifications

  • 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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