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Summary

i am an experienced Regulatory Affairs (ra) professional in the Pharmaceutical Industry, with extensive regional and international experience in a wide variety of ra related topics: e.g. european registration procedures, regulatory Strategy development, regulatory submissions & life cycle maintenance activity, product deletions & divestiture projects, merger-triggered ra Compliance, cross-functional Project Management. besides broad ra experience in the pharma industry, i have also been working for several years for the belgian Health authorities as well as in public pharmacies which complements well and gives me a good and full insight and knowledge on the entire medicines approval process and supply environment. being a reliable and well-organized teamplayer with good Analytical Skills, i am at my best when working in multi-disciplinary & cross-functional teams where i can share my gained technical know-how and expertise to achieve team goals. 

contact details: e-mail: ggjdegreef@gmail.com; mobile: +32 474 533 915

Experiences

Current Experience

  • Manager (External) Pandemic Influenza Registration Management (as Altran consultant)

    Wavre, Belgium
    Since July 2017

    ra support and guidance for registration activities - essentialy life cycle management - linked to gsk pandemic flu Vaccines portfolio, with main focus on international markets.

    RA support and guidance for registration activities - essentialy Life Cycle Management - linked to GSK pandemic flu vaccines portfolio, with main focus on International markets.

  • Senior Expert (RA), LISC Division

    Brussels, Belgium
    Since May 2015

Past Experience

  • RA SME in "Marketing Authorisation Transfer (MAT)" team (as Altran consultant) Wavre, Belgium

    September 2015 --- June 2017

    global ra support, counselling and overall coordination of the Marketing authorization transfers worldwide from novartis Vaccines & Diagnostics to gsk, following the acquisition of the novartis Vaccines & Diagnostics Vaccines portfolio (except flu) by gsk.

  • Director Reg Affairs, Europe Regulatory Integration Liaison

    January 2011 --- October 2014
    Planning, execution and tracking of regional merger-triggered (re)registration / ra activity. product divestiture / product deletion projects execution. aligning regulatory activity & Planning in full concertation with manufacure / Logistics / supply & business plans and priorities.

  • Director Reg Affairs, RAE Therapeutic Area Lead Anti-infectives & Ophthalmo

    April 2010 --- January 2011
    development & implementing the pan-european regulatory Strategy for key products / projects of the anti-infectives and Ophthalmology franchise. people management.

  • Several Global Reg Affairs - Europe positions (Manager / Associate Director / Director)

    September 2002 --- March 2010
    - coordination & execution eu maa dossier update prior to eu enlargement of accession countries - european regulatory Strategy for key products/projects - supervision & counseling of gra-eu managers and administrative staff - involved in sp / organon integration processes and Planning

  • Pharmacist / Expert

    January 1995 --- January 2002
    medicinal products registration activity for the secretariat of the belgian medicines commission. appointed belgian cpmp representative (from 1996 to 2002).

  • Fuctionary responsible pharmacist

    January 1988 --- January 1995
    responsible Pharmacist in a public Pharmacy / officina.

Personality

Self Assessment :
Analytical thinkingAttention to detailApproachabilityCollaborationCoordinationKindnessTrust

Knowledge

LinkedIn Assessment :
Regulatory affairsPharmaceutical IndustryProject ManagementRegulatory submissionsRegulatory Strategy DevelopmentTeam LeadershipIntegrationStrategyEMASupply ChainCPMRPDCPProduct Information ManagementCross-functional CoordinationAnalytical SkillsProject PlanningPrescription DrugsGeneric DrugsOrphan DrugsFDADrug Development

Skills and Expertise

Self Assessment :
Analyze data Create SOPsApprove Label Master SheetApprove patient informationCreates a collaborative team environmentDesign information leafletDevelop regulatory strategyGenerate regulatory submissions Labeling compliance with local regulationsLate-stage regulatory filing (MAA, BLA)Regulatory documentationRegulatory submissionsTranslate protocol into packaging and labeling requirements

Education

  • Pharmaceutical Sciences in from Free University of Brussels, Belgium in 1986

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Full Proficiency

Work Preferences

  • Work From Home:
    No
  • International:
    Yes

Area / Region

Brussel, België

Others

Driving License
  • Yes

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