Biologics Regulatory Publishing Professional

1 day ago


Alleppey, Kerala, India beBeeBiologics Full time ₹ 9,87,654 - ₹ 12,34,567
Regulatory Publishing Specialist

We are seeking a highly skilled professional to manage BLA submissions in eCTD format using Veeva Vault eCTD Publishing.

Key Responsibilities:
  • Prepare and manage BLA (Biologics License Application) submissions in accordance with global health authority requirements.
  • Compile, format, and publish regulatory documents according to global health authority guidelines.
  • Ensure compliance with regulatory requirements and internal processes.
  • Perform quality control of eCTD submissions, including file structure, hyperlinks, and metadata.
  • Collaborate with cross-functional teams 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.
  • 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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