Publishing Specialist

1 day ago

Davangere, Karnataka, India beBeeregulatory Full time ₹ 12,00,000 - ₹ 15,00,000
Job Summary

The BLA Regulatory Publishing Specialist will play a pivotal role in preparing and managing submissions for regulatory approval.

This specialist will utilize Veeva Vault eCTD Publishing to compile, format, and publish regulatory documents according to global health authority requirements.

A successful candidate will demonstrate expertise in ensuring compliance with regulatory guidelines (FDA, EMA) and internal processes.

Cross-functional collaboration is essential for this role, as the specialist will work closely with various teams to gather and manage content.

Strong organizational skills and attention to detail are crucial for meeting deadlines and delivering high-quality results.

Key Responsibilities:

  • Prepare and manage BLA submissions using Veeva Vault eCTD Publishing.
  • Compile, format, and publish regulatory documents according to global health authority requirements.
  • Evaluate and ensure compliance with regulatory guidelines (FDA, EMA) and internal processes.
  • Collaborate with cross-functional teams to gather and manage content.
  • Track submission timelines and deliverables to meet regulatory deadlines.
Required Skills & Qualifications:
  • Expertise 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.
  • Precise attention to detail with strong organizational skills.
  • Fundamental communication skills to collaborate with multiple stakeholders.
  • Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.

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