The Quality Management Systems Associate ensures quality and compliance of the facility with applicable regulatory requirements. These activities may include reviewing documents and data, conducting systems or process-focused audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analyses and reporting metrics where required, as well as performing quality / compliance training, as need...
The Regulatory Affairs Associate is responsible for regulatory submissions and maintaining submission information in a proper Regulatory Affairs systems. The incumbent work cross-functional with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company SOPs. The incumbent is also responsible for preparation of labeling and artwork, eCTD compilat...
