Bio-Pharmaceutical Regulatory affairs consultant
Since January 2014
Consultant in matters of Regulatory Affairs with emphasis on cmc section, my specialty lies in the area of biologicals (Vaccines, Antibodies, recombinant Proteins). i have a strong science background in Life Sciences (Molecular and Cellular Biology) and i am well versed in Project Management. my main drawback: i don't function without coffee, so companies without coffee availability are a no go for me. Consultant in matters of Regulatory Affairs with emphasis on CMC section, my specialty lies in the area of Biologicals (vaccines, antibodies, recombinant proteins). I have a strong science background in life sciences (molecular and cellular biology) and I am well versed in project management. My main drawback: I don't function without coffee, so companies without coffee availability are a no go for me.
Sr. Associate Regulatory Affairs, BiologicalsOctober 2010 --- January 2014
my working field is situated in the biologicals portfolio (biotech derived products, Vaccines, bio-Pharmaceuticals), encompassing current and emerging european (and global) guidelines and regulations, small interaction with us region. i provide Technical Support for a variety of product, scientific and regulatory issues which involves all aspects of Product registration ( registration, Clinical, and technical parts of dossiers). i follow up projects, ascert and maintain the proper project timelines. working under aggressive timelines
PhD in Bioscience EngineeringJanuary 2006 --- September 2010
Protein Engineering, Protein Expression, molecular biology. i focused on antibody development and antibody engineering of single domain Antibodies. development of sound Scientific methodology, Project Management, translational development from idea to functional experiments.
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Phd in Bio-engineering sciences from Vrije Universiteit Brussel in 0000
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