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Summary

my role can be summarised as supporting the ambitious growth aspirations and the expanding range of novel products being developed by belchim crop protection through: people management, input to cross-functional teams, higher management and external stakeholders, co-management of regulatory activities with an emphasis on operational and Teamwork aspects, support implementation of regulatory strategies for submissions and datacalls, provide operational regulatory input throughout product life cycle, support Negotiation with regulatory authorities and experts, advocate for science-based pragmatic and flexible guidelines and requirements, organize and guide the Personal Development of the regulatory team members, and implement the continuous improvement and optimisation of belchim regulatory processes.

Experiences

Current Experience

  • Regulatory Planning Manager


    Since May 2015
    responsible for the operational functioning of belchim's expanding regulatory team in general and every team Member in particular; and, therefore, accountable for the strategic preparation, management and follow up of all operational processes of the workflow throughout the whole submission process within the regulatory belchim crop protection team. supporting the ambitious growth aspirations of belchim through the Personal Development of the regulatory team members and the continuous improvement and optimisation of its regulatory processes. Responsible for the operational functioning of Belchim's expanding Regulatory Team in general and every Team member in particular; and, therefore, accountable for the strategic preparation, management and follow up of all operational processes of the workflow throughout the whole submission process within the Regulatory Belchim Crop Protection team. Supporting the ambitious growth aspirations of Belchim through the personal development of the Regulatory Team members and the continuous improvement and optimisation of its Regulatory processes.

Past Experience

  • Senior Biotechnology Regulatory Affairs Manager

    March 2009 --- April 2015
    manager of eu ra team (4 people); providing regulatory advice throughout the products' lifecycle to cross functional teams; preparing and ensuring timely submission of Applications for authorisation to import gmos to the eu; responding to requests from efsa and eu regulatory authorities; monitoring impact of new regulatory requirements to ensure their appropriate implementation; and, representing the company in relevant industry associations.

  • External Evaluator of Research Proposals

    October 2003 --- January 2013
    external Expert evaluator of Research proposals from small and medium sized enterprises within the 7th framework programme of the european commission. since 2003.

  • Regulatory Affairs Manager

    November 1999 --- January 2008
    responsible for preparing and managing numerous import and cultivation regulatory submissions to eame, and responding to questions from the european Food Safety authority (efsa) and national competent authorities against tight timelines. thorough understanding of regulatory requirements and of the business environment throughout products development and Commercialization.

  • Postdoctoral Researcher

    January 1996 --- January 1999
    Research into potential Formulations for the application of antifungal Proteins for Food preservation; evaluation of genetically modified tomatoes expressing sweet tasting Peptides; and, preparation of field trial Applications for genetically modified organisms.

  • Laboratory Technician

    September 1993 --- May 1996
    Purification and Characterization of mutated forms of heat-stable forms of nadp-glutamate dehydrogenases from neurospora crassa.

  • PhD student

    January 1992 --- January 1996
    Protein Engineering, biochemical Characterization, expression and crystallisation of mutated forms of fungal polyphenol oxidases responsible for enzymatic browning; use of bioinformatic programmes, DNA sequencers and other biochemical and molecular biology techniques; development of excellent interpersonal and Communication Skills; and, establishing a network of contacts in academia, Food Industry and european Research centres.

  • Hospital Assistant

    July 1988 --- July 1990
    assistant to nurses and doctors working at the emergency room and various types of Hospital wards.

  • Commercial agent

    June 1972 --- June 1988
    comprehensive commercial and customer focused experience gained by working in the family-owned business since an early age. i had to support my parents throughout the year after my school hours, but particularly during the two seasons when demand for our articles (toys and stationary) was highest: xmas and summer holidays.

Knowledge

LinkedIn Assessment :
BiotechnologyRegulatory affairsLifesciencesmolecular biologyCrop ProtectionAgricultureTechnology transferGeneticsRegulatory submissionsBiochemistryAgrochemicalsR&DAgronomyAgribusinessGenomicsToxicologyChemistryscienceAnalytical ChemistryChromatographyProtein chemistryLaboratoryMicrobiologyDNABiofuelsImmunologyHPLCCommercializationLife Sciences

Education

  • PhD in Molecular Biology from The University of Reading in 1997
  • MSc in Biotechnology from Universidad de Oviedo in 1992
  • BSc in Fundamental Biology from Universidad de Oviedo in 1991

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

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