· Ensure compliance with data privacy, security, and protection regulations, including the EU and UK GDPR · Balance risks...
Experience supporting regulatory security submissions, ensuring compliance with FDA Cybersecurity Guidance (2025), EU MDR, NIST...
Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity). Excellent communication...
with US and international regulatory standards (FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). Review and support validation activities...
. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited....
including INDs, NDAs, BLAs, IND amendments, IMPDs and CTA submissions, EU and Rest of World (ROW) submissions. Lead the... submissions across US, EU, and global markets. Experience building and scaling teams in a high-growth, agile environment...
working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive. Working... knowledge of EN 62366 and EU Medical Devices Regulation. Capable of working independently with minimal supervision High...
as a subsidiary of Cipla (EU) Limited....
direct-to-disposition capabilities to European Union (EU) and emerging markets - Optimize sortation operations for the...
as a subsidiary of Cipla (EU) Limited....