E-Submissions Regulatory Publishing Expert

18 hours ago


Vizag, Andhra Pradesh, India beBeePublishing Full time ₹ 9,00,000 - ₹ 12,00,000
Regulatory Publishing Specialist

This is a key role within the organization where you will be responsible for managing and publishing regulatory documents in eCTD format.

  • You will work with cross-functional teams to gather content, compile and format documents according to global health authority requirements.
  • Prior experience in Life Sciences / Pharma regulatory publishing is mandatory for this position.

Requirements

  • Strong experience in Veeva Vault eCTD Publishing for BLA submissions is required.
  • You must have hands-on experience in preparing eCTD sequences and publishing ready dossiers.
  • Good communication skills are necessary to collaborate with multiple stakeholders.

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 and internal processes.
  4. Perform QC of eCTD submissions, including file structure, hyperlinks and metadata.


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