pbWork Schedule /b /ppStandard (Mon-Fri) /ppbEnvironmental Conditions /b /ppOffice /ppbJob Description /b /ppJoin Us as a Regulatory Affairs Specialist – Make an Impact at the Forefront of Innovation /ppWe 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. /ppAs 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. /ppWhat You’ll Do: /pulliReview country essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist. /liliReview site essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.



/liliNotifies EDP Submitter via email of review outcome detailing requested revisions and/or corrected documents when deficiencies are noted. /liliReview revised packs to ensure deficiencies were resolved and communicate review outcome to the SSU Specialist. /liliTracks EDP review details in the applicable data tracking system. /liliMaintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines. /li /ulpEducation and Experience Requirements: /pulliGood English language (written and oral) communication skills as well as local language whereapplicable /liliGood attention to detail and quality as well as editorial/proofreading skills /liliGood interpersonal skills to work effectively in a team environment /liliGood computer skills including the use of Microsoft Word, Excel, Power Point; capable of learningnew technologies /liliBasic organizational, time management, and planning skills to create and follow timelines, conductlong-range planning, adapt to changing priorities and handle multiple projects /liliGood negotiation skills /liliCapable of working independently with direction and exercising independent judgment /liliBachelor's degree/previous experience comparable to 2+ years /li /ulpThermo 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. /p #J-18808-Ljbffr

📌 Sr/Regulatory Affairs Specialist - FSP - EMEA (Italia)
🏢 Thermofisher Scientific
📍 Italia