
Veeva eCTD BLA Publisher
2 weeks ago
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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