Job descriptionPrepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD Publishing.Hands-on experience with Docubridge and Lorenz Validator for regulatory submissions.Strong background in Regulatory Publishing with knowledge of global regulatory requirements (FDA, EMA).Experience in Life Sciences / Pharma regulatory publishing.Proficient in Adobe Acrobat Pro and Microsoft Office Suite.Skilled in working with GDMS / Mediva for document management.Experienced in collaboration tools such as SharePoint and Communicator.