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

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

Principal Regulatory Affairs Specialist – Global Clinical Trial Applications

Key skills