Veeva eCTD BLA Publisher

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