Syneos Health · 1 week ago
Regulatory Publishing Specialist (eCTD )
United States
Full-time
Remote
Mid LevelSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. The Regulatory Publishing Specialist (eCTD) will support the publication of regulatory data and information, ensuring compliance with defined processes and operating procedures, while collaborating with team members to deliver quality submissions to global regulatory authorities.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
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, and 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, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others)
Takes lead role in preparing full application submission builds
Troubleshoots issues with eCTD builds and provide 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, perform 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
Qualification
Required
Moderate experience in a regulatory environment with preference given to drug/device/biologic-related industry
Good working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel
Experience with relevant software such as Extedo's eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat, Documentum, Ezsubs, IMS Word for Windows, and Access
Good communication, organizational, and interpersonal skills
Ability to work independently and to understand and carry out detailed instruction
Attentive to the detail and accuracy of information
Ability to work concurrently on several projects, each with specific instructions that may differ from project to project
Preferred
Experience with electronic publishing of regulatory submissions preferred
Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred
Knowledge of submission requirements of various markets such as USFDA, EMA etc. an advantage
Benefits
Company car or car allowance
Health benefits to include Medical, Dental and Vision
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
Flexible paid time off (PTO) and sick time
Company
Syneos Health
Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization.
Founded in 1985
10001+ employees
H1B Sponsorship
Syneos Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2024 (26)
2023 (49)
2022 (63)
2021 (84)
2020 (63)
Funding
Current Stage
Public CompanyTotal Funding
$524.65M2023-09-28Private Equity
2023-05-10Acquired
2021-03-01Post Ipo Secondary· $524.65M
Leadership Team
Costa Panagos
Chief Executive Officer
Michael Bonello
Executive Vice President and Chief Financial Officer
Recent News
2026-01-09
Company data provided by crunchbase