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Elke Gurschke
Senior Regulatory Affairs

Elke has a Master's degree in drug regulatory affairs and is Profil's expert for all regulatory aspects for clinical trials.

Regulatory Affairs

Short Bio

After her studies of Nutritional Sciences, Elke has worked for several years as Pharmaceutical Representative for two different pharmaceutical companies. She also gained experience as Scientific Writer for the patients' homepage Rheuma-Online.de, and as Quality Management Representative in a medical practice before she started working at Profil in 2007. In 2009 she became a student of Drug Regulatory Affairs which she completed with a Master’s Degree (MDRA) in 2011. Since starting at Profil, she has acquired extensive knowledge of all regulatory aspects in clinical trials, making her your and our main contact in this regard.

Selected Achievements and Work Experience

2018 -	Senior Regulatory Affairs Manager, Profil GmbH, Neuss, Germany
2009 - 2018	Regulatory Affairs Manager, Profil GmbH, Neuss, Germany
2009 - 2011	Studies of Drug Regulatory Affairs, Rheinische Friedrich-Wilhelms-University, Bonn, Germany; final degree: Master of Drug Regulatory Affairs (MDRA) Master’s Thesis: Best Practice Guide for Regulatory Affairs in a German CRO
2007 - 2009	Executive Administrator Clinical Science, Profil GmbH, Neuss, Germany
2007	Advanced training and certification as Quality Management Representative (LVQ/TÜV)
2005 - 2007	Executive Assistant & Quality Management Representative, Dr. Langer, Düsseldorf, Germany
2004 - 2006	Scientific Writer “Rheuma-Online”, Meerbusch, Germany
1988 - 1992	Pharmaceutical Representative, Wyeth Pharma GmbH, Münster, Germany
1985 - 1987	Pharmaceutical Representative, Smith Kline Dauelsberg GmbH, Munich, Germany
1984	Advanced training and certification as Pharmaceutical Representative
1979 - 1984	Studies of Nutritional Sciences, Justus-Liebig-University, Gießen, Germany; final degree: Nutritionist (Dipl. oec. troph.)