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Head of Regulatory Affairs
As a member of the PA&PLM team, you are the end responsible and in charge of operational management and system management of all regulatory affairs activities related to products on the BeLux market. This to ensure compliance with cGMP regulatory requirements and the Pharma Quality Manual & Policies.
Operational team lead for all activities related to regulatory affairs management for BeLux. This includes (non-imitatively):
• Submission and maintenance of MRP/DCP/CP and national approvals
• Communication with local health authorities, consultants, regulatory competence centers und internal departments (Marketing, Supply Chain, Market Access etc.)
• Maintenance of Approval documents and Approval-Archives incl. Master Files & Server-Databases
• Creation of SmPCs and PILs
• Obtain CNK codes for all products
• Lifecycle management of BeLux portfolio / MA’s
• Cost Management and Budget oversight
• Support various Headquarter / RCC Projects
• Development and implementation of SOP's for Regulatory Affairs procedures and accountabilities
Guarantee smooth communication flows between all internal and external stakeholders.
Guarantee efficient and transparent execution of the tasks in support of legal requirements and business needs.
Author, review and approve GxP documents and reports like SOP’s, KPI trends & performance reports, and technical or quality investigations related to RA processes.
Follow-up of all RA related change controls.
Provide technical guidance, mentoring and support to other departments (where relevant) on RA processes.
Perform and document root cause investigations in case of deviations from the process and propose and execute corrective and preventive measures.
Drive process optimization for operational excellence. Training and development of RA team members, recruiting, succession planning (in alignment with superior).
Represent organisation at trade organizations and at health authorities regarding (changes in) regulatory affairs legislation.
Master degree (preferable in pharmaceutical sciences)
Tri-lingual (Min 3 out of these 4 languages: Dutch, English, French, German)
Experience with regulatory affairs
Min 5 year work experience
minimum 5 years
Higher Scientific Degree
Dutch, English, French
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