cybersecurity standards, GxP data integrity requirements, and applicable regulatory guidelines (FDA, EMA). Maintain compliance...
and commercial manufacturing Regulatory requirements for biologics (FDA, EMA, ICH) Modalities such as monoclonal antibodies...
setting. Demonstrated knowledge of applicable CMC regulatory requirements (FDA, EMA, and other major health authorities...
coding process by reviewing Preliminary and Held for Billing status visit notes in EMA. You will be responsible...
submission activity. Experience with FDA advisory committee or EMA oral explanation preparation. Experience working on due...
of GCP regulations and guidelines, including ICH, FDA, EMA, and PMDA requirements. Experience in performing GCP-related...
., FDA, PMDA, MHRA, EMA, etc..) including inspection preparation, response coordination, remediation activities...
, selectivity). Quality & Compliance Ensure compliance with GLP, GCP, 21 CFR Part 11, and relevant regulatory guidance (FDA, EMA... guidance for bioanalytical methods (ICH, FDA, EMA). Experience supporting audits and inspections. Preferred Qualifications...
Lead interactions and negotiations with FDA, EMA, and global regulators Partner cross-functionally to align regulatory... and approvals Deep expertise across FDA, EMA, and international regulatory frameworks Strong NCE and clinical development...
of Manufacturing or Validation experience in a GMP manufacturing environment is required Strong understanding of FDA and EMA...