Aktuelle Jobs im Zusammenhang mit Lonza CMO/CDMO Regulatory Expert - Visp - Lonza Group Ltd.
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Manager, Regulatory Affairs
Vor 7 Tagen
Visp, Schweiz Lonza VollzeitTitle: Manager, Regulatory Affairs (CMC)Hybrid working pattern: 2 WFHLocation: Basel or VispRelocation support is provided – subject to criteria.Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working...
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Regulatory CMC Expert
Vor 7 Tagen
Visp, Schweiz Lonza VollzeitJob Description:The Regulatory Affairs Manager will be responsible for coordinating regulatory activities across various stages of biologics projects. This includes authoring and reviewing Module 3.2 dossier sections, representing the Regulatory Affairs department in project teams, and leading submission-related activities to ensure timely delivery of...
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Manager, Regulatory Affairs
vor 1 Woche
Visp, Schweiz Lonza Group Ltd. VollzeitManager, Regulatory Affairs page is loadedManager, Regulatory AffairsLocation: CH - Visp, CH - BaselTime Type: Full timePosted On: Posted YesterdayJob Requisition ID: R61013Title: Manager, Regulatory Affairs (CMC)Hybrid Working Pattern: 2 WFHRelocation support is provided – subject to criteria.Today, Lonza is a global leader in life sciences operating...
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CMC Documentation Manager
Vor 7 Tagen
Visp, Schweiz Lonza VollzeitKey Responsibilities:As a Regulatory Affairs Manager at Lonza, your responsibilities will include authoring and reviewing Module 3.2 dossier sections, tracking and negotiating source document availability, and preparing responses to health authority submission review questions.You will represent the Regulatory Affairs department in project teams, lead...
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Regulatory Labeling Expert Pharmaceutical
Vor 4 Tagen
Visp, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
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Manager, Regulatory Affairs
vor 3 Wochen
Visp, Schweiz TN Switzerland VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
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Lonza Global Engineering Team Member
Vor 4 Tagen
Visp, Schweiz Lonza VollzeitJob FunctionThis is an exciting opportunity to join our Lonza Global Engineering Team as a Senior Project Engineer. You will be responsible for supporting the planning, construction, and start-up of units and plants in the Black Utilities Infrastructure sector.Your key responsibilities will include developing and verifying ideas and requests, generating...
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Process Expert Msat
Vor 3 Tagen
Visp, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
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Associate Principal Scientist
Vor 3 Tagen
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
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QA Pl Drug Product
Vor 4 Tagen
Visp, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
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Associate Principal Scientist, R&d
Vor 4 Tagen
Visp, Schweiz Lonza VollzeitSwitzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
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Program Manager
Vor 6 Tagen
Visp, Schweiz Lonza VollzeitSwitzerland, Monteggio - Switzerland, VispToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...
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Group Leader Process Experts
vor 3 Wochen
Visp, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely...
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Compliance Director
Vor 7 Tagen
Visp, Schweiz Lonza VollzeitKey ResponsibilitiesImplement and maintain quality systems and processes, meeting regulatory requirements and expectations.Monitor and communicate compliance status and risk of the site to management.Conduct educational initiatives to explain and promote compliance concepts across the Visp site.You will interface and collaborate with global quality systems...
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Product Safety Manager
vor 1 Woche
Visp, Schweiz Lonza Vollzeit**Product Safety Specialist (f/m/d)**: Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...
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Manager, Msat Process Validation
vor 1 Woche
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DSP Process Expert MSAT
vor 5 Stunden
Visp, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
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QA Expert
vor 5 Stunden
Visp, Schweiz Lonza VollzeitS enior QA Specialist (Hybrid) - Qualification Utilities Location: VISP Hybrid Working Model (3 days in the office, 2 days WFH) Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working...
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Single-use Technology Expert
Vor 5 Tagen
Visp, Schweiz Lonza VollzeitToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...
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Cleaning Expert Production
Vor 3 Tagen
Visp, Schweiz Lonza VollzeitSwitzerland, VispLonza ist heute ein weltweit führendes Unternehmen im Bereich Life Sciences, welches auf drei Kontinenten tätig ist. Wir sind in der Wissenschaft tätig, jedoch gibt es keine Zauberformel dafür, wie wir die Arbeit angehen. Unsere wichtigste wissenschaftliche Lösung sind talentierte Mitarbeitende, die zusammenarbeiten und Ideen...
Lonza CMO/CDMO Regulatory Expert
vor 1 Woche
The Regulatory Affairs Manager will be responsible for the following key areas:
Regulatory Support:
- Provide regulatory support and advice for internal and external customers.
- Develop and implement regulatory strategies to meet business needs.
Regulatory Coordination:
- Coordinate regulatory activities for clinical development, product license applications, and life cycle management.
- Work closely with cross-functional teams to achieve project objectives.
Compliance:
- Ensure compliance with regulations and Lonza procedures.
- Perform regulatory assessments for deviations, change controls, and VCNs.
Requirements:
- Master's degree in a relevant field or equivalent experience.
- At least 5 years of experience in preparing and authoring M.3.2 CMC dossier sections is essential.
- Previous experience in CMO/CDMO environment is advantageous.
- Expertise in ICH guidelines and EU and US regulatory requirements for Biologics.
