Regulatory Affairs Associate Director – EU Regulatory Lead

🕒 vor 29 Tagen

🇧🇪 Belgien – Remote

⏰ Vollzeit

🟠 Senior

🚔 Compliance

👻 Geisterscore 12%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Thermo Fisher Scientific

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1956

🏥 Gesundheitswesen

📦 Logistik

🏭 Fertigung

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific ist der weltweite Marktführer im Dienste der Wissenschaft mit einem Jahresumsatz von mehr als 40 Milliarden US‑Dollar. Ihre Mission ist es, Kunden dabei zu unterstützen, die Welt gesünder, sauberer und sicherer zu machen – indem sie die lebenswissenschaftliche Forschung vorantreiben, komplexe analytische Herausforderungen lösen, die Produktivität in Laboren steigern und die Gesundheit von Patienten durch Diagnostik sowie die Entwicklung lebensverändernder Therapien verbessern. Mit einem globalen Team bietet das Unternehmen innovative Technologien und pharmazeutische Dienstleistungen über Marken wie Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon und PPD.

Beschreibung

• Provide strategic, operational and tactical regulatory insight on pre-approval and post-approval activities • Guide filing strategy and coordinate disciplines to ensure timely filings with EMA and applicable EMEA agencies • Oversee regulatory affairs vendors involved in marketing authorization filings • Contribute hands-on to regulatory filings and related activities • Provide regulatory leadership for post-approval activities • Monitor, interpret and communicate changes to the global regulatory landscape • Serve as regulatory affairs business partner to local commercialization teams • Partner with medical, legal, quality, PV and distribution teams on regulatory input for business decisions • Connect assigned project-team strategy with broader global regulatory and development teams • Lead review and provide technical advice for regional and global regulatory submissions • Provide regulatory strategy advice and technical expertise to internal and external clients • Oversee key client projects and ensure quality performance • Manage project budgeting and forecasting • Identify out-of-scope contract activities and coordinate contract modifications • Collaborate with business development on pricing, new business presentations, proposals and budgets • Oversee matrix/project leadership, training and guidance for junior team members • Ensure compliance with organizational and departmental SOPs and WPDs • Participate in and lead launch, review and project-team meetings • Lead departmental initiatives and project teams • Liaise with local country regulatory authorities and clients • Travel occasionally to domestic and international sites

🎯 Anforderungen

• Advanced degree required; PhD or PharmD strongly preferred • Comparable to 12+ years of experience; minimum 10 years’ experience in regulatory affairs within pharmaceutical organizations • Strong emphasis on EMA regulatory frameworks • At least one end-to-end regulatory submission process, preferably with the centralised procedure • Experience in rapidly growing pharmaceutical organizations advantageous • Thorough understanding of the drug development lifecycle • Demonstrated expertise in orphan drug development • Knowledge of the global regulatory landscape, particularly Europe, Switzerland, the UK, Israel and the Middle East • Ability to lead and coordinate critical regulatory documents for medicinal product approval and lifecycle management, including EU regulatory strategy and PIPs • Track record of successful engagement with regulatory and health authorities • Mastery of English language, written and oral, and local language where applicable • Exceptional attention to detail, quality, editorial and proofreading skills • Advanced computer skills, including Microsoft Word, Excel and PowerPoint • Organizational, time management and planning skills • Professional negotiation skills • Ability to work independently and exercise independent judgment • Advanced understanding of regulatory requirements and procedures for clinical trial authorization, licensing and lifecycle management • Expert knowledge of ICH and other global regulatory guidelines • In-depth understanding of regulatory specialty areas such as preclinical, clinical, CMC and publishing • Advanced understanding of medical terminology, statistical concepts and guidelines • Analytical, investigative and problem-solving skills • Understanding of budgeting and forecasting • Executive presence, consultation and presentation skills • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered

🏖️ Vorteile

• Fully remote work arrangement • Standard Monday–Friday work schedule