Senior Regulatory Affairs Lead, Benelux

Il y a 3 heures
PuursSintAmands, Flanders, Belgique Pauwels Consulting Temps plein
pOur client, a prominent pharmaceutical organization, is seeking an experienced professional to lead regulatory activities within the Benelux region. The role focuses on ensuring the quality and compliance of regulatory data and processes while managing marketing authorizations for medicinal products.brstrongResponsibilitiesbr/strongulliManage the preparation, submission, and follow-up of registration dossiers, renewals, and variation dossiers for medicinal products. /liliLead the initiation, review, and implementation of label and artwork changes to ensure full compliance with regional regulations. /liliProvide strategic regulatory expertise to internal stakeholders and participate in launch planning and business unit meetings. /liliSupport complex projects including marketing authorization transfers and legal entity changes across the regional market. /liliDraft and review local and global SOPs, work instructions, and other quality-related documentation. /liliOversee the handling of CPP and ancillary document requests for emerging markets and maintain internal regulatory databases. /liliCoordinate with production plants and hubs to manage out-of-stock notifications and artwork approvals.br/li /ulstrongRequirementsbr/strongulliYou have a Bachelor’s degree in a scientific or related discipline. /liliYou bring 8+ years of experience in regulatory affairs, conformance, or compliance within the pharmaceutical industry. /liliYou possess advanced knowledge of EU and global regulatory procedures, marketing authorizations, and drug development practices. /liliYou have experience working in a GMP environment and utilizing regulated document management tools. /liliYou’re an organized and analytical professional with strong skills in technical writing and stakeholder influencing. /liliYou have a perfect command of Dutch with good knowledge of English.br/li /ulstrongNice to Havesbr/strongulliMaster's, MBA, or PhD in a scientific field. /liliExperience with advanced digital regulatory systems and innovative compliance solutions. /li /ul /p

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