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 .