Compliance

• ICS kontrollerini uygulamak ve yürütmek, kontrolleri gerçekleştirmek, açıkları belirlemek ve bunların çözülmesine destek vererek mevzuata ve iç gereksinimlere uyumu sağlamak.
• AEO Yıllık Faaliyet Raporu sürecinden sorumlu, doğru veri analizi, konsolidasyonu ve bulguların doğrulanması; düzeltici işlemleri takip etme ve süreç iyileştirmenin sağlanması.
• Gümrük değeri ile ilgili maliyetlerin beyanını yapmak ve Vergi ve Muhasebe departmanlarıyla koordinasyon sağlamak.
• Gümrük ve diğer ilgili mevzuatlardaki değişiklikleri günlük olarak izlemek, bunların şirket süreçleri üzerindeki etkilerini analiz etmek ve gerekli tedbirleri almak.

Senior Customs Compliance Control Specialist

• Lead local regulatory submission activities for new marketing authorization applications, lifecycle management activities, label changes, technical updates, packaging updates, and post-approval variations for assigned products
• Prepare, compile, and submit local dossiers in line with Turkish legislation and Health Authority requirements, ensuring high quality and timely delivery
• Manage daily interactions with Turkish Health Authorities, including TİTCK/MoH, to support approvals, respond to questions, and close regulatory follow-up activities
• Design and execute GMP strategies, prepare GMP files, support inspections, manage renewals, and ensure timely GMP approvals
• Coordinate regulatory timelines and provide strategic regulatory guidance to internal stakeholders, ensuring alignment with commercial priorities and business objectives
• Support labeling, artwork development, Turkish translations, packaging compliance, and product information updates in line with local requirements
• Monitor and communicate changes in Turkish pharmaceutical legislation, regulatory policies, and packaging guidelines, providing proactive regulatory intelligence to the business
• Build strong partnerships with local commercial teams, Medical, Market Access, distributors, global regulatory colleagues, and external stakeholders
• Maintain regulatory compliance across marketed products, ensuring all activities are performed according to local and corporate standards
• Help navigate a fast-paced and evolving environment where processes may not always be fully established, bringing a proactive and solution-oriented mindset

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Senior Customs Compliance Control Specialist

Regulatory Affairs Manager