NonStop Consulting
Senior Manager Regulatory Affairs
📍 Amsterdam Region, Netherlands
We are seeking a strategic and experienced Regulatory Affairs leader to oversee the full spectrum of regulatory activities across Europe, with extended oversight into Australia and New Zealand. This position plays a pivotal role in the development, submission, and lifecycle management of marketing authorizations for a branded pharmaceutical portfolio, including new chemical entities (NCEs). You will be the single point of accountability for aligning regulatory strategy with business objectives and ensuring compliance with evolving global requirements.
Key Responsibilities
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Lead European regulatory strategy for pre- and post-approval activities, including MAAs, scientific advice, PIPs, and lifecycle management.
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Ensure dossiers and submissions are developed to the highest standards of quality, aligned with the Target Product Profile (TPP).
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Serve as the primary regulatory contact to health authorities and manage interactions for assigned products.
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Maintain compliance with applicable EU directives and regulations (2001/83/EC, 726/2004, 1234/2008/EC), and oversee product artwork and labelling updates.
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Provide cross-functional leadership and support teams across Regulatory Affairs, Medical Affairs, Market Access, PV, and Quality.
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Manage internal resources and external service providers, contributing to budgetary efficiency and operational excellence.
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Guide local RA teams and junior colleagues, fostering development and knowledge transfer within a matrixed global structure.
What We’re Looking For
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10+ years of experience in pharmaceutical Regulatory Affairs, including 5+ years in branded or NCE environments.
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Deep knowledge of EU regulatory procedures (CP/DCP/MRP), dossier structure (CTD/eCTD), and product lifecycle management.
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Skilled in influencing regulatory authorities and internal stakeholders, with strong project ownership and problem-solving ability.
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Familiarity with EU regulatory compliance frameworks, GMP/GDP/GCP, and promotional material review processes.
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Strategic mindset with hands-on capability to drive execution and compliance in a fast-paced, cross-functional setting.
This is a high-impact role offering broad regional scope, regulatory leadership, and direct influence on business-critical outcomes. Ideal for an expert who thrives in a collaborative, international environment and is ready to shape regulatory strategy at scale.
