Sr/Regulatory Affairs Specialist - FSP - EMEA
Pubblicato il 17-10-2026 - Thermofisher Scientific in Bardi
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 whereapplicable
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 learningnew technologies
Basic organizational, time management, and planning skills to create and follow timelines, conductlong-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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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