Professional Information
Senior Regulatory Affairs Consultant
Independent Consultant
Education, Honors & Awards
Ludwig-Maximilians Universität München
PHD Veterinary Medicine- Ludwig-Maximilians Universität München, 1987 (1987)
Personal Information
Travel; Reading; Fluent in English and German Language
More than 25 years
regulatory project management, well organized, leadership by example, team motivation, attention to details, timeline oriented
Alexandra Alexandra is a Senior Regulatory Affairs Consultant with over 20 years experience working in the Pharmaceutical and Biotechnology Industry within small, medium and large organizations, both as an employee and consultant. Throughout her career she developed an in-depth knowledge on all aspects of drug development, quality systems and regulatory project management across Canada, United States and Europe with strong quality and compliance focus, high attention to detail, and a proven track record of delivering on time. Alexandra successfully built high performance RA teams and fostered key relationships with companies in-house, their customers, partners, vendors, as well as with regulatory agencies and industry group. When not working she enjoys travel, and reading.
Regulatory Submissions; Regulatory Affairs; FDA; Pharmaceutical Industry; Drug Development; Clinical Development; Regulatory Requirements; Biotechnology; Immunology
Websites & Social

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