BrightOwl Loader Loading

Experiences

Current Experience

  • 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.

  • Site Compliance Network Member


    Since January 2014
    site Compliance (quality and Regulatory Affairs aspect of registered products) Site Compliance (quality and regulatory affairs aspect of registered products)

Past Experience

  • Sr. Associate Regulatory Affairs, Biologicals

    October 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 Engineering

    January 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.

  • affiliated with

    January 2005 --- September 2010
    Research antibody Engineering

Knowledge

LinkedIn Assessment :
PersistenceResults FocusedAnalytical AbilitiesLife Sciencesmolecular biologyResearchMonoclonal AntibodiesBiotechnologyR&DRegulatory affairsBiochemistryCell biologyImmunologyCell CultureWestern BlottingVaccinesELISAEUProblem SolvingChallenge DrivenLifesciencesEuropean UnionGood Laboratory Practice (GLP)SOPRegulatory submissionsPharmaceutical IndustryClinical trialsRegulatory Requirements

Education

  • Phd in Bio-engineering sciences from Vrije Universiteit Brussel in 0000

Area / Region

Mechelen, België

Others

Driving License
  • No

Similar Candidates

Other Candidates in Belgium

Other Candidates in Mechelen

Other similar Candidates in Mechelen

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like