Sr/Regulatory Affairs Specialist - FSP - EMEA

Job description

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 where applicable   - 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 learning new technologies   - 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   - Good negotiation skills   - Capable of working independently with direction and exercising independent judgment   - Bachelor's degree/ previous experience comparable to 2 + years