Wir haben weitere aktuelle Stellen in diesem Bereich, die Sie unten finden können
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Corporate Drug Regulatory Affairs Manager
vor 2 Monaten
Bad Homburg, Deutschland Viatris VollzeitMeda Pharma GmbH & Co KG At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
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Regulatory Affairs Manager
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Viatris VollzeitCompany Overview: At Viatris, we envision healthcare not merely as it exists, but as it ought to be. We act with determination and are uniquely positioned to provide stability in a landscape of changing healthcare demands.Our Mission: Viatris empowers individuals globally to lead healthier lives at every stage of their journey.Our Approach: We achieve this...
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Manager of Corporate Drug Regulatory Affairs
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Viatris VollzeitCompany Overview:Meda Pharma GmbH & Co KG, part of Viatris, is dedicated to transforming healthcare by addressing the evolving needs of patients worldwide. We strive to empower individuals to lead healthier lives at every stage.Role Overview:The Corporate Drug Regulatory Affairs Manager plays a crucial role in ensuring compliance and excellence in our...
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Manager of Corporate Drug Regulatory Affairs
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Viatris VollzeitCompany Overview:Meda Pharma GmbH & Co KG is part of Viatris, a company that envisions healthcare as it should be. We are committed to providing stability in a rapidly changing healthcare landscape.Role Overview:The Corporate Drug Regulatory Affairs Manager plays a pivotal role in ensuring compliance and excellence in regulatory practices within the...
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Manager of Corporate Drug Regulatory Affairs
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Viatris VollzeitCompany Overview: Meda Pharma GmbH & Co KG, part of Viatris, envisions healthcare as it should be, acting decisively to meet the evolving needs of the healthcare landscape. Our mission is to empower individuals globally to lead healthier lives at every stage. Role Overview: The Corporate Drug Regulatory Affairs Manager plays a pivotal role in ensuring...
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Manager of Corporate Drug Regulatory Affairs
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Viatris VollzeitCompany Overview:Meda Pharma GmbH & Co KG, a part of Viatris, is dedicated to transforming healthcare to meet the evolving needs of patients globally. We are committed to providing high-quality, trusted medications and fostering partnerships that enhance patient health.Role Overview:The Corporate Drug Regulatory Affairs Manager plays a pivotal role in...
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Corporate Drug Regulatory Affairs Manager
vor 2 Monaten
Bad Homburg, Deutschland Viatris VollzeitMeda Pharma GmbH & Co KG At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...
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Automation Engineering Specialist in Pharmaceuticals
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 VollzeitJob Overview:We are seeking a Senior Automation Project Engineer to manage intricate and demanding work packages within the pharmaceutical sector. This role encompasses various domains such as Package Units, Clean Media Automation, Environmental Monitoring Systems, Process Control Systems, and System Integration throughout all project phases, from initial...
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Lead Automation Engineer in Pharmaceutical Projects
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 VollzeitJob Overview:We are seeking a Senior Automation Project Engineer to take charge of intricate work packages within the pharmaceutical sector. This role encompasses various domains, including Package Units, Clean Media Automation, Environmental Monitoring Systems, Process Control Systems, and System Integration. You will be involved in all project phases, from...
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Project Coordinator in Pharmaceutical Engineering
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland customfield3 VollzeitBecome a Key Player as a Project CoordinatorAre you a detail-oriented professional with experience in project oversight within the pharmaceutical sector? Do you have strong interpersonal skills and a passion for assisting your team? If this resonates with you, we invite you to consider the role of Project Coordinator within our Project Management division....
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Business Development Manager
vor 3 Wochen
Bad Säckingen, Baden-Württemberg, Deutschland eschbach GmbH VollzeitPosition: Sales Manager DACH - Enterprise Software SolutionsWe are seeking a seasoned Sales Professional to promote our software solutions to clients within the pharmaceutical and chemical sectors across the DACH region.Key Responsibilities: Identify and engage with pivotal clients in the Chemical and Pharmaceutical industries Formulate and implement a sales...
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Regional Sales Manager
vor 3 Wochen
Bad Säckingen, Baden-Württemberg, Deutschland eschbach GmbH VollzeitPosition: Sales Manager DACH - Enterprise Software SolutionsWe are seeking a seasoned Sales Professional to promote our software solutions tailored for clients in the pharmaceutical and chemical sectors within the DACH region.Key Responsibilities:Identify and engage with major clients in the Chemical and Pharmaceutical industriesFormulate and implement a...
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Regional Sales Manager
vor 3 Wochen
Bad Säckingen, Baden-Württemberg, Deutschland eschbach GmbH VollzeitPosition: Sales Manager DACH - B2B Software SolutionsWe are seeking a skilled Sales Professional to promote our software solutions to clients within the pharmaceutical and chemical sectors across the DACH region.Key Responsibilities: Identify and engage with major clients in the Chemical and Pharmaceutical sectors Formulate and implement a sales strategy...
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Sourcing Manager Nutrition
vor 2 Monaten
Bad Homburg, Deutschland FRESENIUS_KABI VollzeitTargets of the position: The focus of this role is on supplier management for API and Ingredients for Parenteral and Enteral Nutrition, including selection, maintenance, performance review, international contract negotiations and development agreements, as well as working closely with key account and technician representatives from the supplier and...
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Senior Market Access
vor 1 Monat
Bad Vilbel, Deutschland Walker Cole International VollzeitWalker Cole International is partnering with a global pharmaceutical company to appoint a Senior Market Access & Pricing Manager (Europe). The Senior Market Access & Pricing Manager (Europe) will be based in the UK or Germany on a hybrid basis and will focus on the market access planning of a range of speciality innovative medicines.The key responsibilities...
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Supplier Relationship Manager for Nutrition
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI VollzeitPosition Overview: This role is centered on managing supplier relationships for Active Pharmaceutical Ingredients (API) and Ingredients specifically for Parenteral and Enteral Nutrition. Responsibilities include supplier selection, ongoing maintenance, performance evaluations, international contract negotiations, and development agreements, while...
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Assistant Production Manager
vor 2 Wochen
Bad Krozingen, Baden-Württemberg, Deutschland ADECCO VollzeitWe are offering a remarkable opportunity for an Assistant in Production Management within a dynamic environment.Key Responsibilities:Provide support to the production manager in daily operationsAssist in the planning and execution of technical initiativesEngage in project-related tasksManage staff scheduling and allocationAddress staff shortages and manage...
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Assistant Production Manager
vor 3 Wochen
Bad Krozingen, Baden-Württemberg, Deutschland ADECCO VollzeitWe are pleased to present an intriguing opportunity for an Assistant in Production Management within a reputable organization.Key Responsibilities:Provide support to the production manager in daily operationsAssist in the planning and execution of technical initiativesEngage in project-related tasksManage staff scheduling and allocationAddress staffing...
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Assistant Production Manager
vor 3 Wochen
Bad Krozingen, Baden-Württemberg, Deutschland ADECCO VollzeitOpportunity Overview:An engaging role has emerged for an Assistant in Production Management within a reputable organization.Key Responsibilities:Provide support to the production manager in daily operationsAssist in the planning and execution of technical initiativesEngage in project-related tasksManage staff schedules effectivelyAddress staff shortages and...
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Regional Sales Manager
vor 3 Wochen
Bad Säckingen, Baden-Württemberg, Deutschland eschbach GmbH VollzeitSales Manager Europe | B2B Enterprise Software Solutions (m/w/d)Employment Type: Permanent, Full-timeWe are seeking a skilled Sales Manager to lead our efforts in the European market. In this role, you will be responsible for:Identifying and engaging with prominent B2B clients within the chemical and pharmaceutical sectors across EuropeFormulating a...
CDRA Manager Pharmaceutical
vor 2 Monaten
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference. Every day, we rise to the challenge to make a difference, and here’s how the role CDRA Manager Pharmaceutical (m/f/d) will make an impact:
Key responsibilities for this role include:
examination, preparation, coordination, and processing of regulatory documents
pharmaceutical quality documentation (CTD – module 3),
pharmaceutical development
manufacturing and quality control
pharmaceutical technology
pharmacological-toxicological documentation
as well as pharmaceutical expert reports,
risk-benefit-description for medicinal products with regard to pharmaceutical pharmacological topics
coordination of clinical and non-clinical documentation with clinical research, medical information, and drug safety
handling of marketing authorization application procedures (new submissions, line extensions, variations) worldwide, as well as registration maintenance activities (eg variations, renewals)
contact to authorities on national and international level
preparation and discussion of licensing strategies with national and international authorities
pharmaceutical-regulatory support and advice to other departments and business units (e.g. of the Qualified Person acc. § 15 German Drug law) regarding pharmaceutical topics before / during / after approval at national and international level
support of QA activities (e.g. change control, PQR)
support of drug information/ labelling activities
support of pharmacovigilance related activities (e.g. Risk Management Plans, Company Core Data Sheets, PSURs)
training of employees of the CDRA department with regard to pharmaceutical topics
participation in the training and education of pharmacists (e.g. pharmacy students in the context of the third training section according to AAppO)
The minimum qualifications for this role are:
completed university degree in pharmacy, according to the approbation regulations for pharmacists (AAppO)). A detailed description of the know-how acquired during the studies in pharmacy can be found in Appendix 1 to § 2 (2) AAppO
at least 3 years of experience in regulatory affairs
knowledge of essential regulatory requirements globally
ability to plan and execute regulatory projects with special consideration of the pharmaceutical and pharmacological know-how
excellent communication skills, a real team player
ability to establish working contacts with authorities
excellent skills in English language
knowledge in standard EDV programs (e.g. Word, Excel, PowerPoint).
At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
