Principal Regulatory Affairs Specialist - CTA (Clinical Research Field)

Candidates should possess a Bachelor's degree or an advanced degree, or equivalent relevant formal academic/vocational qualification. A proven track record of experience in global regulatory strategies, bid defense meetings, leading global regulatory projects, and client-facing roles is required. Essential skills include an excellent command of English (written and oral), strong attention to detail, exceptional interpersonal and negotiation skills, advanced computer proficiency, and excellent organizational, time management, and planning abilities. A deep understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, including expert knowledge of ICH and other global regulatory guidelines, is also necessary.