Regulatory Publishing Specialist; eCTD

Regulatory Publishing Specialist (eCTD )

Updated: January 14, 2026
Location: Toronto, ON, Canada

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate about changing lives.

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Under limited supervision, will support filtering, cleaning, migration, analysis, reporting and publication of regulatory data and information, undertaken according to defined processes and operating procedures, which will be subject to internal and external audit.

Under limited supervision and with minimal guidance from more senior service line colleagues:

• Performs Assembler tasks within the document publishing system, including, but not limited to, creating publications, modifying outline, assigning and transforming documents, adding cross references, compliance checking, Hyper‑linking, bookmarking, rendering multiple documents to PDF, creation of external links, completion of Modules 1-5 in eCTD format, compilation of NeeS, compilation of paper submission, publishing and validation.
• Performs publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing.
• Performs QC tasks within the electronic publishing system and QC of the published output, including internal QC and QC of client documentation.
• Creates, keys, and assembles client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo’s eCTDManager and eSUBmanager, Core Dossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others).
• Takes lead role in preparing full application submission builds.
• Troubleshoots issues with eCTD builds and provides guidance to the entry level publishers.
• Provides assistance and guidance to entry‑level publishers.
• Reviews documents for legibility, completeness, and accuracy.
• Logs and tracks regulatory documents, publications, and other relevant materials.
• Organizes and compiles regulatory documentation, performs pagination, clean‑up, and duplication tasks.
• May receive and deliver client information/documents, with limited supervision.
• Provides alternatives for completing assigned tasks.
• Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities.
• Able to prioritize and multi‑task a number of projects.

• Moderate experience in a regulatory environment with preference given to drug/device/biologic‑related industry, and experience with electronic publishing of regulatory submissions preferred.
• Good working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel.
• Experience with relevant software such as…