Principal Reg Affairs Specialist (Clinical Trial Applications) at Thermo Fisher Scientific

The following skills are required to be successful in this position:

• preparation and assembly of global regulatory submissions (CTA)
• interacting with sponsors,
• review and assess clinical trial regulatory documents,
• review and assess scientific literature. 
• manages project teams and preparation
• participate in launch meetings, review meetings and project team meetings.
• Experience with bid defense meetings

Qualifications - External

What the role requires you to have:

• 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
• Knowledge of the global clinical trials landscape

Knowledge, Skills and Abilities:

• 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
• Experience in leading global regulatory projects for Clinical Trial Applications
• 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