Job Description

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