and commercial manufacturing Regulatory requirements for biologics (FDA, EMA, ICH) Modalities such as monoclonal antibodies...
Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) Ability to travel 50...
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...
verbal and written communication skills. Excellent interpersonal and customer service skills. Working knowledge of EMA...
cybersecurity standards, GxP data integrity requirements, and applicable regulatory guidelines (FDA, EMA). Maintain compliance...
authorities (e.g., FDA, PMDA, MHRA, EMA, etc..) including inspection preparation, response coordination, remediation activities...
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...
Skills/Experience: Experience with FDA advisory committee and/or EMA oral explanation. - Experience working on due...
updated with FDA/EMA labeling guidelines and regulations. Participate in labeling negotiations with agencies resulting in product...