The Publishing Officer will support regulatory submission publishing activities for global markets as part of the Publishing project. The role focuses on the preparation, compilation, and publishing of regulatory submissions in multiple electronic formats, ensuring compliance with regional regulatory authority requirements and internal quality standards.

Key Responsibilities

Perform regulatory publishing activities in

eCTD, NeeS, ePaper, and ACTD formats .

Support submissions across

EU, US, Canada, Australia, GCC, ASEAN, and other global regions .

Compile, publish, and validate regulatory submissions in line with health authority requirements.

Ensure accuracy, consistency, and technical compliance of published submissions.

Coordinate and plan assigned publishing projects in collaboration with internal stakeholders.

Perform quality checks and address validation findings prior to submission.

Maintain submission documentation and ensure proper version control.

Work effectively within defined timelines while managing multiple submissions.

Required Qualifications

Bachelor's degree in





Life Sciences

or a related discipline.

3+ years of experience

in Regulatory Affairs / Regulatory Operations with hands-on

eCTD publishing

exposure.

Experience working on

international, EU, and RoW submissions .

Technical Skills Mandatory:

Experience with

eCTD and NeeS publishing .

Robust knowledge of

electronic document management systems (eDMS) .

PDF preparation and editing using

Adobe Acrobat Pro .

Hands-on experience with

DocuBridge

(Preferred

Familiarity with

ISI Toolbox / Evermap

(bookmarks, hyperlinks, TOC creation).

Basic understanding of

Regulatory Affairs processes and submission lifecycle .

Highly organized and methodical approach to work.

Strong attention to detail and quality mindset.

Ability to manage priorities and work under tight timelines.

Adaptable and comfortable working in a global, remote environment.

Clear communication and collaboration skills.

#J-18808-Ljbffr

📌 Regulatory Publishing Officer (Montreal)
🏢 ProductLife Group
📍 Montreal