Regulatory Publishing Expert

2 days ago

Mount Abu, Rajasthan, India beBeePublishing Full time ₹ 12,00,000 - ₹ 15,00,000

Job Overview:

We are seeking a highly skilled Regulatory Publishing Specialist to join our team.

The ideal candidate will have experience in Veeva Vault eCTD Publishing for BLA submissions and a strong understanding of global regulatory requirements.

  • Prior experience in Life Sciences / Pharma regulatory publishing is essential.

Responsibilities:

Key Responsibilities:

  • Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.
  • Compile, format, 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 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.

Benefits:

This role offers a unique opportunity to work in a dynamic environment and contribute to the success of our organization. As a member of our team, you will have the chance to develop your skills and expertise in regulatory publishing.

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