Regulatory Publishing Expert

2 days ago

Salem, Tamil Nadu, India beBeePublishing Full time ₹ 10,79,000 - ₹ 19,97,000
Job Title: Regulatory Publishing Specialist – Veeva eCTD

We are seeking a skilled Regulatory Publishing Specialist to join our team. As a key member of our regulatory publishing group, you will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.

  • 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.
  • Evaluate compliance with regulatory guidelines (FDA, EMA) and internal processes.
  • Perform quality control 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.
  • Familiarity with global regulatory requirements (FDA, EMA).
  • Hands-on experience in preparing eCTD sequences and publishing ready dossiers.
  • Excellent organizational skills and attention to detail.
  • Good communication skills to collaborate with multiple stakeholders.
  • Prior experience in Life Sciences / Pharma regulatory publishing is mandatory.

About this role

This role requires a strong understanding of regulatory publishing principles and practices. The ideal candidate will have a proven track record of delivering high-quality regulatory documents and submissions.

What we offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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