eCTD Regulatory Publishing Professional

2 weeks ago


Tiruppur, Tamil Nadu, India beBeePublishing Full time ₹ 9,00,000 - ₹ 10,80,000
Regulatory Publishing Specialist

Key Responsibilities:

  • Manage eCTD submissions for BLA applications.
  • Compile and publish regulatory documents in accordance with global health authority requirements.
  • Ensure compliance with FDA, EMA regulations 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:

  • 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 essential.

What We Offer:

  • A dynamic work environment with opportunities for growth and development.
  • The chance to work with a talented team of professionals in the life sciences industry.
  • A competitive compensation package with benefits.


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