eCTD Regulatory Document Specialist

1 week ago


Nellore, Andhra Pradesh, India beBeePharmaregulator Full time ₹ 20,00,000 - ₹ 45,00,000

Key Job Responsibilities:

  • Manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault Publishing.
  • Compile, format and publish regulatory documents according to global health authority requirements.
  • Evaluate compliance with regulatory guidelines (FDA, EMA) and internal processes.
  • Perform quality control 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:

  • 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 required.


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