Christie Lector

Cmc Regulatory Affairs Specialist @Spectronrx

Zionsville, IN, US

Review regulatory submissions to ensure all aspects of global regulatory and CMC compliance are met and fully support clinical supply. Perform regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process Assist with preparation of regulatory submissions such as BLAs, DMFs, INDs, and NDAs for internal and external customers. Support the regulatory submission forms to support regulatory release and QP certification. Working with QA/QC/ R&D teams to ensure that the manufacturing processes meet the quality requirements and that the product is consistently produced and controlled according to quality standards. Overseeing the scale-up of manufacturing processes from pilot to full-scale production, ensuring consistency and compliance with approved methods Interact closely with pharmaceutical partners and business groups to develop realistic timelines for the introduction of new radiopharmaceuticals and help with customer service and targeting efforts. Ensure that radiopharmaceuticals are produced reliably and in full compliance with all regulatory requirements,(specifically, 21 CFR 212 and 211.) Compile and submit reports on all projects to management and clients as required.

The City College of New York

Bachelor of Science - BS, Biology, General