Biologics License Application

2 weeks ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000

Job Summary

We are seeking a Regulatory Publishing Specialist with expertise in eCTD format publishing using Veeva Vault.

Key Responsibilities:

  • Prepare and manage submissions for Biologics License Applications in compliance with global health authority requirements.
  • Compile, format, and publish regulatory documents according to international standards.
  • Ensure compliance with FDA and EMA guidelines as well as internal processes.
  • Perform quality control of submissions including file structure, hyperlinks, and metadata.
  • Collaborate with cross-functional teams to gather and manage content.
  • Track timelines and deliverables to meet regulatory deadlines.

Required Skills & Qualifications:

  • Proven experience in Veeva Vault eCTD Publishing.
  • Knowledge of global regulatory requirements.
  • 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.
  • Previous experience in Life Sciences / Pharma regulatory publishing is mandatory.

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