Susanne Burek
Freiberuflich, Regulatory Affairs Management (AM + MP) + PV-Signalmanagement + BtM Consulting, Burek Consulting
Nordrhein-Westfalen (NRW), Deutschland
Werdegang
Berufserfahrung von Susanne Burek
Bis heute 10 Jahre, seit Juli 2014
Regulatory Affairs Management (AM + MP) + PV-Signalmanagement + BtM Consulting
Burek Consulting
16 y RA-Consulting/Expert advice+support f. Regulatory Affairs Strategy, Operations, RA LCM (MAA, variations, worksharing, renewals, PI+CTD update, gap analyses, MA transfer, Submissionmanagement etc.)/RA expert statements for due dilligence/ Rx, OTC / Countries: EU, CIS, CEFTA, APAC, MENA, LATAM, OCEANIA, USA, Canada / on site + remote / Project-Site: Worldwide / IT: Documentum, SAP, LIQUENT, RIMS, TrackWise, CESP DETAILED PROJECT LIST ON DEMAND / https://www.freelance.de/Freiberufler/85489
1 Jahr und 6 Monate, Juli 2012 - Dez. 2013
Drug Regulatory Affairs Manager CMC
Kohne Pharma GmbH; UCB Pharma GmbH
MA Maintenance CMC, Change Control, Life-Cycle-Management, XEVMPD, CCDS-Update, Execution of Global Product Recall, Referral-Procedures, tight collaboration with Manufacturer, Pharmacovigilance, Quality Assurance, Publishing Team, Labeling Team; Supported Countries: - entire EU - Switzerland - Ukraine - CIS-Countries - Turkey - Korea - China - Mexico - Venezuela
4 Jahre, Aug. 2008 - Juli 2012
Scientific Employee / Drug Regulatory Affairs Manager
Licensing / Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Focus: - European MA - New Registrations and Repeat Use Procedures - Variations - Renewals - Creation of a Knowledge Management WIKI Products: - Phytopharmaca - Traditional Drugs - Vitamines - Minerals
1 Jahr und 7 Monate, Jan. 2007 - Juli 2008
Scientific Employee / Permission Narcotics
Bundesopiumstelle / Bundesinstitut für Arzneimittel und Medizinprodukte
- Management of special permissions in line with §3(2) BtMG for medically-supervised self-treatment with medicinal cannabis - Management of special permissions for clinical trials on narcotics
Employment exchange, Recruitment Agency, Employer Service, Coaching of young and older unemployed.
1 Jahr und 5 Monate, Feb. 2000 - Juni 2001
Molecular Biologist
Bayer AG
R&D, High Throughput Screening (HTS), signaltransduction, molekularbiology, cellbiology, performance of human gene cloning, vector construction and data evaluation with DNA-Analysis-Software, clone pool analysis, pharmakological characterisation of cell lines using reporter genes
Molekularbiological Reserch on Receptor-Tyrosin-Kinases; Pattern Formation, Signaltransduction; Developmental Biology
Ausbildung von Susanne Burek
1991 - 1999
Biologie
Universität zu Köln
Zoology, Biochemistry, Molekularbiology, Botany
Sprachen
Deutsch
Muttersprache
Englisch
Fließend