Business Development ManagerLuxembourg
Since September 2015
Regulatory Affairs & Technology Transfer Associate Luxemburg City, LuxembourgSeptember 2014 --- August 2015
click to edit position descriptionCustomer 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.
• support regional Sales directors in reviewing and negotiations of contracts and agreements.
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:
• 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).
• optimize internal processes and controls-writing standard business procedures (sbps) and standard operative procedures (sops).
• schedule internal and external meetings, review of confidential agreements, quality agreements, reports, writing meeting minutes.
• maintain a filing and follow-up system for Project Management.
OrganizationAttention to detailAdaptabilityAssertivenessCollaborationAnalytical thinkingCommunicativeCoordinationCreative thinkingDiligenceInterest in knowledgeProblem solving
PharmaceuticalsscienceLaboratory ResearchCustomer ServiceRegulatory affairsQuality Assurance (QA)Technology transferStart up
Skills and Expertise
Software skills: MS Office and SPSS MyFactory ERP system Parallels Desktop Adobe Illustrator Pulse_XP Opticon Vector_NTI Sigmaplot SigmaStat EndNote FACSDiva Axio Observer software ImageJ. Laboratory skills: Molecular and biochemical techniques: Cell culture DNA/RNA extraction RT- PCR Chromatin immunoprecipitation (ChIP) Transfection RNA-interference; immunocytochemistry ELISA Western Blot; Imaging technologies: 6 color flow cytometry (3D Facs Canto)Fluorescence microscopy
Ph.D. in Neuroendocrinology, Immunology from University of Trier in 2013
Master in Pharmaceutical Sciences from Medical University Sofia in 2008
Bachelor in Pharmaceutical Sciences from Medical University Sofia in 2005
Expert has 3 publications (Will be avalible with full profile)