Regulatory Publishing Specialist

3 days ago


Ghaziabad, Uttar Pradesh, India beBeePublishing Full time ₹ 15,00,000 - ₹ 20,00,000
Job Description

Responsibilities:

  • Prepare and manage BLA submissions in eCTD format using Veeva Vault.
  • Compile, format, and publish regulatory documents according to global health authority requirements.
  • Ensure compliance with regulatory guidelines 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

Key Requirements:

  • 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.
What We Offer

A dynamic and supportive work environment that fosters growth and collaboration.

Opportunities to develop your skills and expertise in a rapidly evolving field.

Professional development programs to support your career advancement.



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