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