Requirements

Candidates should possess a Bachelor’s degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification. Previous experience providing regulatory affairs knowledge, skills, and abilities is required, along with expert knowledge of the global clinical trials landscape, understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, and familiarity with ICH and other global regulatory guidelines. Strong command of English (written and oral), excellent attention to detail and quality with strong editorial/proofreading skills, exceptional interpersonal skills for effective teamwork and liaison work, advanced computer skills (Microsoft Word, Excel, PowerPoint), and strong organizational, time management, and planning skills are also necessary. The ability to work independently and exercise independent judgment, along with analytical, investigative, and problem-solving skills, is required.