Laetitia Coudray

Regulatory Affairs Manager at Prolacta Bioscience

Laetitia Coudray has a wealth of experience in the regulatory affairs and scientific fields. Laetitia began their career in 2002 as a Research Assistant at the Institut des Substances Naturelles and a Teaching Assistant at Faculté de Pharmacie Paris XI. In 2006, they became a Post-doctoral Research Associate at TCU, where they discovered and developed three new catalytic reactions. From 2009 to 2010, they were a Post-doctoral Research Associate at the McGill University Health Centre. Laetitia then joined Draths Corporation (acquired by Amyris, Inc.) as a Scientist in 2010, where they developed a batch process transforming muconic acid to caprolactam and improved the Diels-Alder reaction between muconic acid and ethylene in green solvents. In 2011, they moved to Amyris Inc. as a Scientist II, where they enhanced three synthetic processes transforming muconic acid and farnesene to value-added chemicals. In 2013, they became a Scientist at Aurora Algae, Inc., where they led a team of organic and analytical chemists to identify and quantify impurities present in a complex natural extract and improved chemical and purification processes transforming an algae extract to a nutraceutical grade product. From 2014 to 2021, they were at AMPAC Fine Chemicals as a Regulatory Affairs CMC Specialist and Senior Process Scientist, providing CMC regulatory support for the preparation of documents necessary to support DMFs, Responses, Amendments and AR submissions, and scaling up processes under cGMP. Most recently, they joined Prolacta Bioscience as a Regulatory Affairs Manager, where they are responsible for IND authoring, reviewing and managing to submission, and providing regulatory support for entering new markets or maintaining established business by participating to label development and notification for exempt infant formula / FSMP. Laetitia also reviews promotional marketing materials for exempt infant formula and FSMP for USA, Canada, Europe, Middle East, Australia and Latin America.

Laetitia Coudray obtained their Doctor of Pharmacy (Pharm.D.) from Paris-Sud University (Paris XI) between 1996 and 2002. Laetitia then went on to obtain their DEA (Diplome d'Etude Approfondies) - Advanced Postgraduate Degree in Medicinal and Pharmaceutical Chemistry from the same university in 2001-2002. Finally, they completed their PhD in Chemistry from Paris-Sud University (Paris XI) in 2002-2005.

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