Job Description

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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

Skills Required