This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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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 integral 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 t

📌 Sr/Regulatory Affairs Specialist (La Línea de la Concepción)
🏢 Thermo Fisher Scientific
📍 La Línea de la Concepción