Role at a glance
- Job function
-
Legal & Compliance Compliance & Regulatory Affairs
- Salary
- Not Disclosed
- Location
- Sofia, Bulgaria
- Work arrangement
- Remote
- Employment
- Full-time
- Education
- Bachelor's
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About the role
Original posting provided by Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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
Basic 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
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.