risks and issues related to clinical trial delivery. · Ensure trials are conducted in compliance with ICH-GCP, FDA, EMA...
). This position requires hands-on regulatory writing expertise aligned with ICH, FDA, and EMA expectations, strong cross-functional...: Ensure compliance with ICH guidelines, FDA/EMA guidance, company SOPs, and style conventions Contribute to template...
Strong understanding of FDA, EMA, and ICH Health compliance requirements Understanding of industry quality management tools, quality...
Strong understanding of FDA, EMA, and ICH Health compliance requirements Understanding of industry quality management tools, quality...
environment. Ensure adherence to global regulations (GxP, FDA, EMA), manage IT risk, and oversee Business Continuity and Disaster...
processes. World regulatory expertise (EMA, Health Canada, PMDA). Expertise in product development for clinical and commercial...
, FDA, EMA, etc. Leading gap analysis to ensure alignment with changes in global regulations Strategizing and drafting...
, and familiarity with expectations from regulatory agencies (FDA, EMA, etc.). Excellent interpersonal skills and a strong client...
interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages...) and managing regulatory authority correspondence Knowledge of global regulatory requirements for clinical development (FDA, EMA...
interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages...) and managing regulatory authority correspondence Knowledge of global regulatory requirements for clinical development (FDA, EMA...