Sr/Regulatory Affairs Specialist - FSP - EMEA
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:
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Review country essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.
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Review site essential documents for completeness, accuracy, and quality as defined by the Essential Document Compliance (RDC) checklist.
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Notifies EDP Submitter via email of review outcome detailing requested revisions and/or corrected documents when deficiencies are noted .
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Review revised packs to ensure deficiencies were resolved and communicate review outcome to the SSU Specialist.
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Tracks EDP review details in the applicable data tracking system.
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Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines.
Education and Experience Requirements:
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Good English language (written and oral) communication skills as well as local language where applicable
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Good attention to detail and quality as well as editorial/proofreading skills
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Good interpersonal skills to work effectively in a team environment
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Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
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B asic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
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Good negotiation skills
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Capable of working independently with direction and exercising independent judgment
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Bachelor's degree/ previous experience comparable to 2 + years