Regulatory Publishing Specialist

4 days ago

Vellore, Tamil Nadu, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

Job Role Overview:

We are seeking a highly skilled Regulatory Publishing Specialist to join our team in the field of eCTD publishing. The successful candidate will be responsible for managing BLA submissions in eCTD format, compiling and publishing regulatory documents, and ensuring compliance with regulatory guidelines.

In this role, you will have the opportunity to work with cross-functional teams to gather and manage content, perform quality control on eCTD submissions, and track submission timelines and deliverables.

Key Responsibilities:
  • Manage BLA Submissions: Prepare and manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing.
  • Compile and Publish Regulatory Documents: Compile, format, and publish regulatory documents according to global health authority requirements.
  • Ensure Regulatory Compliance: Ensure compliance with regulatory guidelines and internal processes.
  • Perform Quality Control: Perform quality control on eCTD submissions, including file structure, hyperlinks, and metadata.
  • Collaborate with Cross-Functional Teams: Collaborate with cross-functional teams to gather and manage content.
  • Track Submission Timelines: Track submission timelines and deliverables to meet regulatory deadlines.
Requirements:
  • Strong Experience in Veeva Vault eCTD Publishing: Strong experience in Veeva Vault eCTD Publishing for BLA submissions.
  • Knowledge of Global Regulatory Requirements: Knowledge of global regulatory requirements.
  • Hands-on Experience in Preparing eCTD Sequences: Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
  • Excellent Organizational and Communication Skills: Excellent organizational and communication skills.

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