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| Position wanted: |
Regulatory Affairs department |
| Job category: |
Biotech |
| Preferred Location: |
Argentina |
| Preferred City-State/County: |
Buenos Aires |
| Objective and Resume Summary: |
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Objective
Challenging position in a regulatory affair/R&D team.
After more than six years in the academy and four years at the regulatory affair department in one of the world’s leading pharmaceutical companies, I am looking for a new challenging and exciting position in a company willing to sponsor my visa. I am asking to consider me as candidate and I strongly believe it will worth it.
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| Skills: |
Computer Skills
Excellent computer orientation
Software: SAP, PowerDocs, Minitab, GraphPad Prism, Microsoft office (all applications).
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| Known languages (and levels): |
English-Very GoodSpanish-GoodOther: Hebrew Mother tongue
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| Type of Employment wanted: |
Full Time
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| Minimum Yearly Salary in Numbers: |
25000 USD
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| Current Location: |
Argentina, Buenos Aires, Vicente López |
| Education History, Qualifications & other additional information: |
| Level of Education: |
Masters
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Education
Oct. 2006 - Oct. 2008 M.Sc in Biotechnological Engineering
Institution: Ben Gurion University, Beer Sheva, Israel
Graduate with distinction
Oct. 2002 - July. 2006 B.Sc in Biotechnological Engineering
Institution: Ben Gurion University, Beer Sheva, Israel
Professional Training
•Generic Drug Approval: Preparing an ANDA for First-Cycle Approval
•Impurities in Drugs: monitoring & regulations
•Six Sigma - Green belt training
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| Work History & Experience: |
| Years of Work Experience: |
3 to 5 Years |
Jan. 2007 – Jan. 2009 Perrigo Pharmaceuticals Ltd; Yeruham, 80500 Israel
Project Manager in Regulatory Affairs Department for the US Market
•Preparation of ANDA in eCTD format, Hybrid format and various post approval submissions such as AR, CBE and PAS.
•Responsible for auditing and approving documents in the plant (manufacturing and packaging orders, product specifications, QC monographs, stability protocols etc.).
•Responsible for implementation of appropriate standard procedures to assure compliance with cGMP regulations.
•Performing analytical auditing of monographs, specification, HPLC and GC chromatograms.
•Review and approval of packaging components during product developments.
•Responsible for USP packaging safety testing during product development, assessment of the required testing, evaluation and approval of the test protocols and reports.
Feb. 2005 - Dec. 2006 Perrigo Pharmaceuticals Ltd; Yeruham, 80500 Israel
Project Manager Assistant in Regulatory Affairs Department for the US Market
•Assistant in auditing and preparing documents for ANDA Submissions (manufacturing orders, packaging orders, specifications, QC monographs, RMS, PMS, stability protocols etc.).
•Performing analytical auditing of monographs, specifications, HPLC and GC chromatograms.
Other Professional Experience
Oct. 2005 - Oct. 2008 Ben Gurion University, Beer Sheva, Israel
•Teaching assistant at the laboratory of analytical chemistry.
•Conducting R&D activities in novel drug delivery systems using opioids as drug model (vesicles encapsulation, purification by gel filtration, performing pain tests, Pharmacokinetics & Pharmacodynamics studies “in vivo”, developing of analytical methods for the process etc.).
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