Regulatory Affairs Specialist
1 mese fa
Job Description:
Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to join our global Regulatory Affairs department – Regulatory Science team. As a pivotal team member, you will lead discussions and coordinate regulatory strategies globally on assigned clinical trials, studies, and projects.
Key Responsibilities:
- Preparation and assembly of global regulatory submissions
- Interacting with sponsors
- Review and assess clinical trial regulatory documents
- Review and assess scientific literature
- Manage project teams and preparation
- Participate in launch meetings, review meetings, and project team meetings
Requirements:
- Expert knowledge of the global clinical trials landscape
- Excellent command of the English language (written and oral) as well as local language where applicable
- 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, PowerPoint; 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 produce 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
What We Offer:
- Competitive salary
- Extensive benefits package based around the health and well-being of our employees
- Flexible working culture
- Collaborative environment
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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