Business Development Manager
Since September 2015
Regulatory Affairs & Technology Transfer Associate
September 2014 --- August 2015
Customer Service & Sales Responsibilities: • Ownership of all sales transactions for selected pharmaceuticals companies globally. • Manage day-to-day working relationships with key suppliers and service providers. • Acknowledge and file incoming Purchase Orders from customers and generate sales quotes, invoices via an ERP system. • Management of supply chain and logistics processes for all shipments to the assigned customers. • Investigate root cause and seek resolution to customer complaints. Technology Transfer responsibilities: • Assisting to the CEO in the liaison between the current and the future Contract Manufacturing Organization (CMO) and ensuring the smooth transfer of the manufacturing know-how. • Maintenance of internal documentary database and ensuring the timely delivery of requested data as well as providing with technical support where and when needed. • Coordinating the activities of the CMOs and following up on the progress of the technology transfer project. Regulatory and Quality Assurance responsibilities: • Optimize internal processes and controls-writing Standard Business Procedures (SBPs) and Standard Operative Procedures (SOPs). • Regulatory support to customers when launching new products and /or expanding their markets. • Ensure on-time preparation and sharing of regulatory and quality documents to address customer needs. • Detect deviations, file in deviation reports, initiate the applicable corrective action (CAPA-procedure).
July 2013 --- September 2014
Academic writing - Articles & Press Releases, Grants & Proposals, Abstracts & Report. Formatting, Design & Development, Editing & Proofreading, Publication support services.
Doctoral Researcher at the Department of Immunology,CRP-Sante
January 2009 --- June 2013
International clinical trials management, project PHD BFR08-073. -Investigation of the genomic effects of cortisol release in healthy subjects in collaboration with the Clinical and Epidemiological Investigation Center at CRP-Santé, Luxembourg. -Investigation of the genomic effects of psychosocial stress in healthy subjects in collaboration with University of Trier, Germany. Ph.D Thesis: Ultradian- and stress-induced glucocorticoid pulsatility and their role in the kinetics of immune and transcriptional responses. Graduated with great honors-MAGNA CUM LAUDE.
May 2008 --- July 2008
Writing a project proposal granted by Fonds National de la Recherche, Luxembourg and successfully completed in 2013, entitled: “Transcriptional activity of hGR and its interaction partners: target genes and their expression kinetics”.
April 2007 --- August 2007
Conducting experiments for a Master project with focus on molecular biology and cancer gene therapy. Training in molecular biology techniques (PCR, Western blot, Transfection, RNA interference).
August 2005 --- September 2006
Final therapeutic decision maker e.g. check counter side effects, therapeutic interaction and overall prescription consistency. Drug inventory management.
Doctor of Philosophy (Ph.D.) in Neuroendocrinology, Immunology from Research Institute of Psychobiology, University of Trier, Germany in 2013
Master of Pharmaceutical Sciences (M.Pharm.) in Pharmaceutical Sciences from Medical University of Sofia in 2008
Bachelor of Pharmaceutical Sciences (B.Pharm.) in Pharmaceutical Sciences from Medical University of Sofia in 2005
Training and Certification
Design and Interpretation of Clinical Trials Certification
PRINCE2 Foundation Certification
PRINCE2 Practitioner Certification