Veeva ETCD BLA Publisher

Prepare 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 .