Join our growing team and grow with us as Beckman Coulter introduces 118 new or improved products over 3 years! The Senior Staff, Regulatory Affairs Professional V is a high-level strategist, individual contributor and subject-matter-expert responsible creating and executing regulatory strategies for premarket activities and managing complex issues that may have significant impact on the […]
Regulatory Affairs Jobs
Amgen is seeking a Regulatory Affairs, Sr. Manager to join our team. To learn more: **Group Purpose:** To support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans. **Job Summary:** •Coordination of global regulatory CMC activities relevant to the […]
Amgen is a values-based organization with a powerful sense of shared purpose towards our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful […]
Diese Stelle ist in Teilzeit 50% (20h/Woche) zu besetzen. **AUFGABENSTELLUNG** + Mitwirkung bei der Einreichung neuer Zulassungsanträge im Rahmen europäischer Zulassungsverfahren + Aufrechterhaltung bestehender Zulassungen einschließlich der Pflege arzneimittelrechtlich geforderter informierender Texte + Qualitätskontrolle von regulatorischen Dokumenten, wie z.B. von Produktinformationstexten und Arzneimittel-Kennzeichnungen + Unterstützung der Regulatory Affairs-Manager bei der Bearbeitung von AMNOG-bezogenen Aktivitäten, wie […]
**SUMMARY** The Regulatory Affairs, SR. Manager will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. The primary responsibilities of this role are to define the strategy and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements, organization and preparation […]
**Position Title:** Senior Clinical Project Manager (Sr. CPM) **Line:** Global Product Development (GPD) / Global Regulatory Affairs (GRA) / Development China (DC) / Clinical Trail Management (CTM) **Location:** China **Role Summary:** The Senior Clinical Project Manager (Sr. CPM) will lead and manage the core cross functional study team and is the single point of accountability […]
null **In this role, you have the opportunity to** The position is the Medical Affairs Director for the Connected Care Business, reporting directly to the Head of Clinical & Medical Affairs of that business. The role is responsible for providing medical leadership across all aspects of clinical safety, throughout product development and life-cycle management. This […]
null **In this role, you have the opportunity to** Contribute to fundamentally improving people’s Health & Well-being, through meaningful innovation. We have a unique opportunity for a Product Marketing Manager to join the highly successful Image Guided Therapy Systems business focusing on the interventional cardiovascular domain. You will enter the multinational environment of the Business […]
null **Respiromix, a Philips Group company that is a leader in the sales of sleep & respiratory care medical devices, is looking for candidates for the position of Quality Assurance Specialist.** **In this role you have the opportunity to** Support quality and regulatory activities as well as support and execute product certifications/ approbations with Competent […]
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