is required Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct...
is required Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct...
submissions to FDA, EMA, NMPA, PMDA, etc. Able to identify data or analytical issues, and assist with providing solutions...
compliance with GxP, FDA, EMA digital regulations Requirements: 8+ years of experience in pharma commercial digital product...
Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA) Experience in team leadership... (EMA/FDA/MHRA) Proficiency in MS Office and electronic quality management systems Fluent in English (Mandarin...
across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH, etc.) supporting R...
, regulatory compliance (GCP, FDA/EMA), pharmacovigilance, and safety reporting. Excellent written, verbal, and interpersonal...
with FDA, EMA, EU MDR, and other applicable global standards. Your Responsibilities Develop, plan and execute global... with FDA (21 CFR Parts 3/4/801/820), EMA/EC (EU MDR and Article 117), and relevant ISO standards . Authority engagement: lead...
(FDA, EMA, NMPA, ICH M10, E6). Exceptional leadership and people management skills with a record of developing scientific...
Objectives: Responsible for authoring TOI documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical...