li>In close coordination with the Infant Formula Premarket Review Staff:
Evaluate analytical methods and protein quality issues;
Evaluations of infant formula notification requests for additional data and information regarding protein efficiency assays and bioassays for determination of protein quality in complex infant formula matrices;
Develop draft guidance for conduct and evaluation of protein efficiency ratio and growth monitoring studies in infant formula submissions;
Respond to and\or meet with industry with regards to the accurate performance of the Protein Efficiency Ratio (PER) requirements under the new Infant Formula Regulation.
This position will aid our federal client's public health risk and/or safety assessments of infant formula submissions by providing consultation to staff on new requirements under the Infant Formula Final Rule and collaborating with regulatory staff to provide guidance to industry with regards to the accurate performance of the PER under the new regulations.