large, sophisticated capital projects in regulated environments (FDA/EMA or similar). Proven ability to lead cross...
qualification activities comply with internal SOPs, cGMP, data integrity principles, and regulatory expectations (e.g., FDA, EMA...
, or Construction Management (advanced degree preferred). 10+ years of experience leading sophisticated capital projects in FDA/EMA...
improvement. You will ensure strict adherence to all regulatory guidelines (e.g., FDA, EMA, DEA) and company quality standards... FDA, EMA, and DEA requirements. You have strong analytical and problem-solving skills, with the ability to use data...
understanding of regulations and industry guidance including but not limited to FDA, Health Canada, EMA, and ICH Engaging...
Planning. Direct line in Americas and EMA regions. Dotted line in AP region. Purpose of the Job: The position manages...
). Support Biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA). Interpret analysis results and ensure...
but not limited to, FDA, EMA, ICH, USP, EP, JP, and CHP Extensive knowledge of analytical method validations and method transfers...
values Advanced systems including Modernizing Medicine’s EMA for efficient EMR and practice management Flexible...
of FDA and EMA regulations and guidelines Excellent organizational, communication, and interpersonal skills. Preferred...