Regulatory Publishing Specialist

19 hours ago


Bengaluru, Karnataka, India beBeePublishing Full time ₹ 9,00,000 - ₹ 18,00,000

Job Overview:

  • We are seeking a Regulatory Publishing Specialist with expertise in eCTD format submissions and Veeva Vault to join our team.

Main 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 quality control 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 in Veeva Vault eCTD Publishing for BLA submissions.
  • Knowledge of global regulatory requirements (FDA, EMA).


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