BrightOwl Loader Loading

Summary

- worked for more that 25 years in a global r&d environment (eu, usa, japan, norway and singapore) as Member of multi-disciplinary project teams aiming at developing innovative Vaccines for all important animal diseases. - manager of a group of (senior) scientific editors biologicals (phd and MSc level). - for merck Animal Health (2nd largest Animal Health company in the world) kept a strict overview of the whole internal and external r&d project portfolio (biologicals) for all species with focus on the business case, governance and agreed project timelines. - Owner of restracon, a consultancy enterprise providing full support on all aspects of Product registration world-wide. special expertise in obtaining Marketing authorizations for biologicals (Vaccines).

Experiences

Current Experience

  • Owner


    Since June 2013
    restracon is a consultancy enterprise providing full support on all aspects of Product registration world-wide. special expertise in obtaining Marketing authorizations for biologicals (Vaccines). the support deals will all aspects of the product i.e. Manufacturing and quality (cmc part); the safety file and the efficacy file and deals both with new products and support for existing products (variations and/or line extensions). apart from regulatory and scientific support, full knowledge available on regulatory processes i.e. central, decentral, mutual recogntion and national procedures. if preferred, the whole regulatory procedure can be taken care of (dossier compilation, q&a, and the coordination of the whole regulatory process). ReStraCon is a Consultancy enterprise providing full support on all aspects of product registration world-wide. Special expertise in obtaining Marketing Authorizations for Biologicals (vaccines). The support deals will all aspects of the product i.e. Manufacturing and Quality (CMC part); the Safety file and the Efficacy file and deals both with new products and support for existing products (variations and/or line extensions). Apart from Regulatory and Scientific support, full knowledge available on Regulatory processes i.e. Central, Decentral, Mutual Recogntion and National procedures. If preferred, the whole regulatory procedure can be taken care of (Dossier compilation, Q&A, and the coordination of the whole regulatory process).

Past Experience

  • Director Global R&D Portfoliomanagement

    June 2008 --- May 2013
    kept a strict overview of the whole internal and external R&D project portfolio (biologicals) for all species with focus on the business case, governance and agreed project timelines.

  • Senior Scientific Editor

    January 1990 --- January 2008
    in this role: - prepared over 20 european regulatory dossiers for Vaccines intended for major animal diseases in all important species (swine, ruminants, poultry, companion animals [dogs, cats and horses] and fish). these dossiers covered all parts of Product Development (production, quality, safety and efficacy) and involved novel antigens, recombinant technology products and multi-component Vaccines (biologicals). - acted as representative of intervet towards heads of regulatory agencies, especially in europe (specific: visited on a frequent base the French regulatory authorities to discuss long standing unsolved issues. eventually brought the whole intervet vaccine portfolio to france) - represented intervet as scientific Expert at oral hearings for the highest european scientific body (cvmp) of the emea, defending successfully the Applications made by the company. - managed of group of 8 (senior) scientific editors biologicals (phd and MSc level)

Knowledge

LinkedIn Assessment :
LifesciencesPharmaceutical IndustryBiotechnologyRegulatory affairsInfectious diseasesGMPTechnology transferImmunologymolecular biologyMicrobiologyValidationR&DPharmacovigilanceVaccinesVirologysciencePoultryVeterinary MedicineRegulatory submissionsClinical DevelopmentClinical trialsGood Laboratory Practice (GLP)BiochemistryBiopharmaceuticalsSOPLife SciencesSOP

Education

  • in from Polytechnics Clinical-Chemistry, Etten Leur, The Netherlands in 1985
  • in from Courses on Financial Management, Business Administration and Leadership in 0000
  • in from Post academic courses in Molecular Biology, Virology, Immunology and Statistics in 0000

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency

Work Preferences

  • Positions I am interested in:
    Regulatory Affairs Consultant
  • Work From Home:
    Yes, 0 to 5 days per week
  • International:
    Yes

Area / Region

Boxmeer, Netherlands

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Netherlands

Other Candidates in Boxmeer

Other similar Candidates in Boxmeer

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like