Regulatory Affairs Manager & Compliance Officer Benelux
Since January 2012
Regulatory Affairs Manager
July 2011 --- January 2012
• Maintain and update existing regulatory authorizations (MRP/DCP) in Belgium, Luxembourg and The Netherlands. • Compile and submit regulatory variations and renewal applications and obtain approval for nationally approved products. • Responsible for interactions with Regulatory Authorities in Belgium, Luxembourg and The Netherlands. • Generate regulatory translations, prepare, review, and approve labeling and perform proof-reading of artwork for Belgium and The Netherlands.
January 2008 --- June 2011
Responsible for implementation of the Quality System and coordination of all QA activities (complaint handling, batch release, technical agreements, audits, change control, CAPA's,...). Acting as the Qualified Person. Coordination of the Regulatory Affairs team (RA officers) to ensure timely approval and registration of pharmaceutical products. Provides support for writing analytical variation dossiers with focus on CMC. Experience with national, MRP and DCP registrations. Keeping abreast of international legislation, guidelines and customer practices. Advising team members and manufacturers on regulatory requirements and strategy. As representative of the New Products Launch team responsible for advising and coordinating of product flow and documentation and specifying storage, labelling and packaging requirements. Develop, manage and maintain good working relationships with Competent Authorities.
Site Compliance Administrator
September 2001 --- December 2007
Responsible for writing the Module 3 (CMC) for the products manufactured at the site (sterile and biological products). Compiling variation dossiers for worldwide submission. RA representative in several project teams, setting up the strategy for the submissions worldwide. Coördinating the implementation of changes at the production site. Responsible for the technical file for medical devices, involved in the Quality Management System and ISO audit for medical devices.
in Industrial Pharmacist from Katholieke Universiteit Leuven in 2001
in Latin - Mathematics from STK in 1995