Sr/Regulatory Affairs Specialist - FSP - EMEA

Work Schedule

Environmental Conditions

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 AffairsSpecialist, you will beresponsibleforthereviewandapprovalofcountry-andsite-levelessentialdocumentsrequiredforsiteactivation.Thedocumentsrequiredforeachstudysiteandcountryaredocumentedinastudy-specificEssentialDocumentCompliance (EDC)ReviewChecklist.Oncefinalstudydocumentsareavailable,theRegulatoryAffairsSpecialistreviewsallrequiredessentialregulatorydocumentation for completeness, accuracyand quality,ensuringthatdocumentationmeetsapplicableregulatoryandstudyrequirementsandsupportstimelysiteactivation.

What You’ll Do:

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

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

• NotifiesEDP 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 communicatereview 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 to2+ years