Regulatory Affairs Jobs

Senior Staff, Regulatory Affairs

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 Analyst ( Analista de Assuntos Regulatórios)

Interprets regulations affecting the operation of the organization (including distributors) and implements policies and procedures to ensure compliance with regulations and regulatory reporting requirements in support of process compliance and product quality. Process, conduct and track investigations and compliance audits. Oversees compliance program and promotes compliant culture. Responsible for compliance reporting and training. Requires Juris […]

Regulatory Affairs Sr Mgr

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 […]

Specialist QA/QP Clinical Trials Supply

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 […]

Senior Associate Regulatory Affairs / Regulatory Affairs Manager (m/w/d) Teilzeit 50%

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 […]

Regulatory Affairs Sr Manager

**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 […]

Sr. Clinical Project Manager

**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 […]

Medical Affairs Director, Connected Care

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 […]

Senior Product Manager IGT Systems

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 […]

Quality Assurance Specialist

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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