Regulatory Publishing Specialist

Syneos Health, Inc.; Remote; GBP 60,000 - 80,000; Full time

Job summary

A renowned healthcare solutions company seeks a Regulatory Publishing Specialist (eCTD) to oversee the publishing of regulatory data and ensure compliance with established procedures. The ideal candidate should have experience in the regulatory environment, strong organizational skills, and proficiency in various publishing software. Responsibilities include document quality control, assembling client submissions, and managing multiple projects simultaneously. This role offers competitive benefits, including health insurance and flexible paid time off.

Benefits

Company car or car allowance

Health benefits (medical, dental, vision)

401k company match

Employee Stock Purchase Plan

Flexible paid time off (PTO)

Qualifications

• Moderate experience in a regulatory environment, preferably in drug/device/biologic industry.
• Strong attention to detail and accuracy in publishing tasks.
• Ability to work independently and multitask multiple projects.

Responsibilities

• Perform QC on the published output and internal documentation.
• Handle publishing tasks in the electronic publishing system.
• Provide guidance to entry-level publishers on documentation.

Skills

Moderate experience in a regulatory environment

Working knowledge of basic computer applications

Knowledge of medical/scientific terminology

Strong communication, organizational, and interpersonal skills

Attention to detail and accuracy

Tools

Extedo eCTDManager

eSUBmanager

CoreDossier

ISI Toolbox

eCTDXpress

eValidator

Acrobat

Job description

Regulatory Publishing Specialist (eCTD)

Updated: Yesterday
Location: GBR-Remote
Job ID: 25104493

Regulatory Publishing Specialist (eCTD) – responsible for filtering, cleaning, migrating, analyzing, reporting and publishing regulatory data and information according to established processes and operating procedures, subject to internal and external audit.

Job Responsibilities

• Perform Assembler tasks within the document publishing system – creating publications, modifying outlines, assigning and transforming documents, adding cross references, compliance checking, hyper‑linking, bookmarking, rendering PDFs, completing eCTD modules, compiling submissions for paper and electronic submission.
• Handle publishing tasks in the electronic publishing system – adding special sheets, applying rules, preparing for publishing.
• Perform QC on the published output – internal QC and QC of client documentation.
• Create, Whilst key and assemble client deliverable documents and submissions using standard publishing systems (Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat, Documentum, Ezsubs, IMS Word for Windows, Access).
• Take lead role in preparing full application submission builds and troubleshoot eCTD build issues.
• Provide guidance and assistance to entry‑level publishers and review documents for legibility, completeness, and accuracy.
• Log and track regulatory documents and publications and organize compiling regulatory documentation, pagination, cleanup, duplication tasks.
• Maintain client information/documents and offer alternatives for task completion.
• Prepare and assemble applications (INDs, NDAs, ANDAs, DMFs, variations đã, routine reports, renewals, etc.) for submission to global regulatory authorities.
• Prioritize and multitask multiple projects concurrently.

Qualifications

• Moderate experience in a regulatory environment, preferably in drug/device/biologic industry with electronic publishing of regulatory submissions.
• Working knowledge of basic computer applications (MS Word, PowerPoint, Excel).
• Experience with Extedo eCTDManager, eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat, Documentum, Ezsubs, IMS Word for Windows, Access.
• Knowledge of medical/scientific terminology, ICH guidelines, regulations, and submission requirements for major markets (USFDA, EMA, etc.).
• Strong communication, organizational, and interpersonal skills.
• Ability to work independently and interpret detailed instructions.
• Attention to detail and accuracy.
• Capability to manage concurrent projects with varying specifications.

Benefits

The benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), company match 401k, Employee Stock Purchase Plan, commissions/bonus, flexible paid time off (PTO) and sick time. Eligibility may vary by location and is subject to applicable paid sick time requirements.

Salary Range

Base salary range represents the anticipated low and high of the Syneos Health range for this position; the actual salary will vary based on candidate qualifications, skills, and proficiency.

Contact Information

Phone: [phone]
Fax: [phone]
Toll-Free: 866 462 7373

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires a reasonable accommodation to complete any part of our application process, please contact us at: [e-mail].