Regulatory Publishing Expert

4 days ago


Kolkata, West Bengal, India beBeePublishing Full time ₹ 10,00,000 - ₹ 15,00,000

Job Overview:

We are seeking a skilled Regulatory Publishing Specialist to join our team. As a key member of the regulatory publishing department, you will be responsible for preparing and managing BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.

The ideal candidate will have strong experience in Veeva Vault eCTD Publishing for BLA submissions, knowledge of global regulatory requirements, and hands-on experience in preparing eCTD sequences and publishing ready dossiers.

  • Key Responsibilities:
  1. Prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
  2. Compile, format, and publish regulatory documents according to global health authority requirements.
  3. Ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
  4. Perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.
  5. Collaborate with cross-functional teams (Regulatory, Clinical, CMC) to gather and manage content.
  6. Track submission timelines and deliverables to meet regulatory deadlines.
  • Required Skills & Qualifications:


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