People

Doris Weber Rüegger
MSc Biomedical Engineering Chemikerin FH
MSc Biomedical Engineering Chemist FH	❖	Owner and director of PHARCONS Pharma Consulting GmbH.
	❖	Long-time, profound experience in the pharmaceutical regulatory field:
		-	Senior regulatory position in a Swiss affiliate of an American pharmaceutical- and consumer goods manufacturer; responsible for all regulatory matters of the OTC division and the medical review of the promotional material.
		-	Regulatory Affairs Manager in the Swiss affiliate of a Japanese pharmaceutical company with sole responsibility of the regulatory department. Main focus on new applications (new active substances, regular and fast track applications) as well as life-cycle management of existing licenses in the Rx field. Additional tasks in the pharmacovigilance area (drug safety officer and deputy, respectively).
		-	Regulatory Affairs Manager in an international consultancy; providing of regulatory services for Swiss clients for Rx and OTC products (inclusive allergens). Implementation of eCTD inclusive training of internal and external regulatory personnel.
	❖	Head of laboratory (inclusive personnel management) in a service laboratory for microbiology. Independent evaluation and result release of the microbiological tests of food, pharmaceuticals, medical devices and environmental samples. Deepened support of the medical device area (field work included).
	❖	Medical laboratory technician in the area of microbiology (in a service laboratory and also in the field of quality assurance and food safety) as well as in different fields in the hospital (clinical chemistry, haematology, immune haematology).
	❖	Languages: German and English (fluent in written and spoken), French and Italian (technical vocabulary).
	Brief profile of Doris Weber Rüegger

Ludwig Weber
Certified technical expert HF corporate processes Certified food technologist HFP
Certified technical expert HF corporate processes Certified food technologist HFP	❖	Quality Manager at PHARCONS Pharma Consulting GmbH.
	❖	2021 start CAS Quality Manager Pharma at University of Applied Sciences and Arts Northwestern Switzerland.
	❖	QA experience in the GMP area (finished product manufacturer).
	❖	Education in the food industry with a higher technical examination as a certified food technologist HFP and as a certified technical expert HF corporate processes.
	❖	In depth, long-standing experience in the areas of production processes, process monitoring, process adjustments and QA/QM (various divisions).
	❖	Team leader incl. personnel management, training of employees.
	❖	SAP-Operator, good IT-user knowledge.
	❖	Languages: German and English (fluent in written and spoken).

Brief profile of Ludwig Weber