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: firstname.lastname@example.org; Mobile: +32 474 533 915
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
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.
Analytical thinkingAttention to detailApproachabilityCollaborationCoordinationKindnessTrust
Skills and Expertise
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
Pharmaceutical Sciences in from Free University of Brussels, Belgium in 1986