Veeva eCTD BLA Publisher

2 weeks ago

Hyderabad, India Zensar Technologies Full time

We are seeking a passionate and detail-oriented Veeva eCTD BLA Publisher to support global regulatory submissions for biologics and BLA products. The ideal candidate will have hands-on experience with Veeva Vault eCTD Publishing , strong knowledge of FDA and EMA guidelines , and a proven track record of compiling, formatting, and dispatching high-quality eCTD submissions.

Key Responsibilities:

  • Prepare, compile, and publish Biologics License Application (BLA) submissions in eCTD format using Veeva Vault and other publishing tools.
  • Format regulatory documents (PDFs) in compliance with ICH and regional specifications , including bookmarks, hyperlinks, metadata , and file naming conventions.
  • Perform quality control (QC) checks on eCTD sequences to ensure submission readiness.
  • Collaborate with cross-functional teams including Regulatory Affairs, Clinical, CMC, and Safety to gather and manage submission content.
  • Manage lifecycle submissions such as initial, variations, AdPromo, Investigator Brochures, Annual Reports, DSURs, and RMPs.
  • Track submission timelines and ensure timely delivery to health authorities (FDA, EMA, GCC).
  • Maintain working knowledge of publishing standards , document management systems , and regulatory compliance tools .
  • Support XEVMPD/Article 57 activities and ensure product data accuracy in client databases.
  • Respond to agency queries and manage feedback using tools like SharePoint, Communicator, and email systems .

Required Skills & Qualifications:

  • 2–5 years of experience in regulatory publishing , specifically with BLA and biologics submissions .
  • Proficiency in Veeva Vault eCTD Publishing , Docubridge , Lorenz Validator , and GDMS .
  • Strong understanding of FDA, EMA, and GCC regulatory requirements .
  • Experience in eCTD sequence building , test publishing , and archiving .
  • Familiarity with XEVMPD , SmPC , PIL , and MedDRA coding workflows.
  • Excellent attention to detail and organizational skills.
  • Strong communication skills and ability to work with cross-functional global teams.
  • Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field .

Preferred Tools & Technologies:

  • Veeva Vault RIM
  • Docubridge / eCTD Express
  • Lorenz Validator
  • Adobe Acrobat Pro
  • Microsoft Office Suite
  • GDMS / Mediva
  • SharePoint / Communicator

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