Regulatory Document Publishing Professional

21 hours ago

Nellore, Andhra Pradesh, India beBeePublishing Full time ₹ 8,00,000 - ₹ 15,00,000

Job Overview:

We are seeking a highly skilled Regulatory Publishing Specialist to join our team. In this role, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.

  • Key Responsibilities:
  • Compile 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: 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.
  • Essential Skills: 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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