Tyler Keady

Managed global Chemistry, Manufacturing, and Controls (CMC) regulatory submissions for assigned products, ensuring compliance with requirements and agency expectations. Collaborated with cross-functional teams to develop regulatory strategies, act as a liaison with agencies, and support labeling/eCTD processes. Provided regulatory expertise, responded to agency inquiries, and maintained ongoing co

Prepared and formatted regulatory submission documents for FDA approval, including PAS, CBE-30, CBE-0, and Amendments, ensuring compliance with regulatory standards. Worked within multilevel approval structures and participated in Change Control processes to update procedures. Led the creation of submission-ready documents using PharmaReady and reviewed labeling materials for accuracy and complian

Assisted in preparing documentation for internal and external audits and collaborated on CAPA processes to address regulatory compliance gaps. Managed document control, data management, and tracking of regulatory submissions and compliance reports. Supported the Change Control process and conducted data reviews for testing results and product release documentation.

Performed quality inspections of incoming materials and finished products, ensuring compliance with regulatory standards and FDA guidelines. Communicated across departments to facilitate timely material releases, supporting production timelines and compliance. Participated in internal and external audits, maintaining documentation and records in line with FDA requirements.

Conducted microbiological and chemical testing of in-process and finished product samples, ensuring compliance with cGMP and FDA quality standards. Prepared analytical reports for FDA submissions, maintaining detailed records of results in compliance with industry regulations.

Generated customer-facing reports based on regulatory compliance testing and sample analysis, contributing to FDA submission documentation. Participated in the maintenance and calibration of analytical instruments, ensuring testing equipment met FDA standards. Followed test methods and SOPs to maintain quality compliance for pharmaceutical products.

Conducted microbiological and chemical testing of in-process and finished product samples, ensuring compliance with cGMP and FDA quality standards. Prepared analytical reports for FDA submissions, maintaining detailed records of results in compliance with industry regulations.