Expert Document Publisher

2 weeks ago

Kottayam, Kerala, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title: Regulatory Publishing Specialist

Overview:

As a Regulatory Publishing Specialist, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.

This role involves compiling, formatting, and publishing regulatory documents according to global health authority requirements.

You will ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.

Additionally, you will perform QC of eCTD submissions, including file structure, hyperlinks, and metadata.

Collaboration with cross-functional teams (Regulatory, Clinical, CMC) is essential to gather and manage content.

Lastly, tracking submission timelines and deliverables is crucial to meet regulatory deadlines.

Key Responsibilities:

  • 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 (FDA, EMA) and internal processes.
  • Perform QC 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).
  • 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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