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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.

  • 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