Marie Dutton Email and Phone Number

• Prepared, reviewed, and submitted high quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions included ANDAs, amendments, supplements, and annual reports.• Represented Regulatory Affairs department in project team meetings and provided regulatory guidance to R&D and Operations teams as appropriate.• Reviewed change control requests and assessed impact of change to the approved ANDA.• Kept abreast of regulatory requirements, including monitoring FDA regulations and standards.

• Prepared and reviewed labeling for new submissions and commercial products.• Coordinated with cross-functional colleagues to ensure appropriate implementation of new labeling revisions and destruction of obsolete labeling.• Monitored FDA websites weekly for changes in RLD labeling.• Ensured timely labeling revisions were made due to RLD updates and commercial plant needs.• Prepared labeling section of annual reports.• Prepared End-User declaration letters.• Assisted in creation or revision of labeling SOPs.• Trained Regulatory Affairs Coordinator on labeling duties.

• Supervised Quality Control Raw Material Team.

• Performed routine and non-routine analysis of raw materials, stability samples, in-process samples, and finished products. Instrumentation included HPLC, GC, AA, DSC, IC, and Karl Fischer.• Trained junior chemists.• Peer reviewed laboratory notebooks.• Revised and updated laboratory SOPs.• Served as Raw Material Coordinator.

• Performed analysis such as viscosity, pH, fineness, color, moisture, and fat content on raw materials and final products. • Tested and stabilized batches of various chocolate products according to specifications. • Monitored and evaluated production line results from each stage of chocolate manufacture from roasting of cocoa beans to molding of coatings into confectionery bars. • Inspected finished goods for quality of flavor and appearance.