Principal Regulatory Affairs Specialist – Global Clinical Trial Applications
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Bulgaria
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Job Level
About the role
- lead discussions and coordinate regulatory strategies globally on assigned clinical trials, studies and projects
- be a pivotal team member with regulatory affairs responsibilities
- provide innovative solutions and global regulatory expertise
- act as a liaison with internal and external clients
- arrange, lead, and report on client and regulatory agency meetings
Requirements
- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 8+ years
- Knowledge of the global clinical trials landscape
- Excellent command of the English language (written and oral) as well as local language where applicable
- Experience with Bid Defense meetings
- Experience in leading global regulatory projects for Clinical Trial Applications
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
- Excellent analytical, investigative and problem-solving skills
Benefits
- award-winning learning and development programme
- competitive salary
- extensive benefits package
- flexible working culture
- work-life balance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesglobal regulatory expertiseclinical trial applicationsattention to detaileditorial skillsanalytical skillsproblem-solving skillsinvestigative skillsorganizational skillstime management
Soft Skills
interpersonal skillsteam collaborationindependent judgmentcommunication skillsplanning skillsadaptabilityclient liaisonleadershipreporting skillsquality assurance