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Proclinical Logo Proclinical · Research and Development

Regulatory Operations Specialist

Czech Republic, Kolín · Job Posted March 19, 2026
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Job Description

Driving flawless regulatory submissions that keep life‑changing oncology and biotech therapies moving forward. Proclinical is seeking a Regulatory Operations Specialist to support regulatory filings and submissions within the oncology and biotechnology sectors. This role focuses on ensuring compliance with FDA and EMA requirements, utilizing eCTD publishing software, and preparing essential documentation. This is a fully remote role based anywhere in Europe.

Job Responsibility

  • Prepare and submit regulatory filings, including INDs, NDAs, MAAs, DSUR reports, and scientific advice documents
  • Utilize eCTD publishing software, specifically DocuBridge from Lorenz, for submission preparation
  • Draft and format 1571 forms, cover letters, and other regulatory documents
  • Ensure proper formatting of documents using MS Word templates and Adobe PDF tools

Requirements

  • Proficiency in regulatory filings for FDA and EMA submissions
  • Hands-on experience with eCTD publishing software, particularly DocuBridge
  • Strong skills in document preparation, including 1571 forms and cover letters
  • Expertise in MS Word formatting and Adobe PDF tools
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