Senior Regulatory Affairs Specialist

Il y a 5 heures

PuursSintAmands, Flanders, Belgique Pauwels Consulting Temps plein

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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. /p h3Key Responsibilities /h3 ul liManage the preparation, submission, and follow-up of registration dossiers, renewals, and variation dossiers for medicinal products. /li liLead the initiation, review, and implementation of label and artwork changes to ensure full compliance with regional regulations. /li liProvide strategic regulatory expertise to internal stakeholders and participate in launch planning and business unit meetings. /li liSupport complex projects including marketing authorization transfers and legal entity changes across the regional market. /li liDraft and review local and global bSOPs /b, work instructions, and other quality-related documentation. /li liOversee the handling of bCPP /b and ancillary document requests for emerging markets and maintain internal regulatory databases. /li liCoordinate with production plants and hubs to manage out-of-stock notifications and artwork approvals. /li /ul h3Qualifications /h3 ul liYou have a Bachelor’s degree in a scientific or related discipline. /li liYou bring 8+ years of experience in regulatory affairs, conformance, or compliance within the pharmaceutical industry. /li liYou possess advanced knowledge of bEU and global regulatory procedures /b, bmarketing authorizations /b, and bdrug development practices /b. /li liYou have experience working in a bGMP /b environment and utilizing bregulated document management tools /b. /li liYou’re an organized and analytical professional with strong skills in technical writing and stakeholder influencing. /li liYou have a perfect command of bDutch /b with good knowledge of bEnglish /b. /li /ul h3Nice to Haves /h3 ul liMaster’s, MBA, or PhD in a scientific field. /li liExperience with advanced digital regulatory systems and innovative compliance solutions. /li /ul

Senior Regulatory Affairs Specialist

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