Sr/Regulatory Affairs Specialist - FSP - EMEA

thermofisher
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🌍 Remote📍 Remote, France📍 Remote, Italy📍 Remote, Portugal📍 Remote, Ukraine📍 Sofia, Bulgaria📍 Spain, SpainFull time

About this role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to serve as the lead over several countries/projects in providing innovative solutions, including regulatory expertise and client interface. As a Regulatory Affairs Specialist, you will be responsible for the review and approval of country- and site-level essential documents required for site activation. The documents required for each study site and country are documented in a study-specific Essential Document Compliance (EDC) Review Checklist. Once final study documents are available, the Regulatory Affairs Specialist reviews all required essential regulatory documentation for completeness, accuracy and quality, ensuring that documentation meets applicable regulatory and study requirements and supports timely site activation.

What You’ll Do:

  • Review country essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist. 

  • Review site essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist. 

  • Notifies EDP Submitter via email of review outcome detailing requested revisions and/or corrected documents when deficiencies are noted. 

  • Review revised packs to ensure deficiencies were resolved and communicate review outcome to the SSU Specialist. 

  • Tracks EDP review details in the applicable data tracking system. 

  • Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. 



Education and Experience Requirements:

  • Good English language (written and oral) communication skills as well as local language where applicable 

  • Good attention to detail and quality as well as editorial/proofreading skills 

  • Good interpersonal skills to work effectively in a team environment 

  • Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies 

  • Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects 

  • Good negotiation skills 

  • Capable of working independently with direction and exercising independent judgment 

  • Bachelor's degree/previous experience comparable to 2+ years 

Frequently Asked Questions

Is the salary disclosed for the Sr/Regulatory Affairs Specialist - FSP - EMEA position at thermofisher?
The salary for this Sr/Regulatory Affairs Specialist - FSP - EMEA role at thermofisher is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Is the Sr/Regulatory Affairs Specialist - FSP - EMEA job at thermofisher remote?
Yes, this Sr/Regulatory Affairs Specialist - FSP - EMEA position at thermofisher is remote, with team members based in Remote, France, Remote, Italy, Remote, Portugal, Remote, Ukraine, Sofia, Bulgaria, Spain, Spain. You can work from home or anywhere in the supported regions.
Is the Sr/Regulatory Affairs Specialist - FSP - EMEA role at thermofisher full-time or part-time?
This is listed as a Full time position. It is posted as a Sr/Regulatory Affairs Specialist - FSP - EMEA role at thermofisher.
How do I apply for the Sr/Regulatory Affairs Specialist - FSP - EMEA position at thermofisher?
Click the "Apply Now" button on this page. You will be redirected to thermofisher's official application portal hosted on workday where you can submit your application directly.
When was the Sr/Regulatory Affairs Specialist - FSP - EMEA job at thermofisher posted?
This Sr/Regulatory Affairs Specialist - FSP - EMEA position at thermofisher was posted on Sep 15, 2026. Apply as soon as possible — early applications are often reviewed first.
Sr/Regulatory Affairs Specialist - FSP - EMEA
thermofisher
Apply for this role ↗

You'll be redirected to thermofisher's official application page on Workday.