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 .