Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Director - Visp - Lonza Biologics Porriño SLU
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Visp, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Associate Director Regulatory Affairs Small Molecules (f/m/d), VispClient:Location:Job Category:OtherJob Reference:3a4171bf38cfJob Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:Today, Lonza is a global leader in life sciences operating across three continents. Our greatest scientific solution is...
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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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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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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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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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Biotechnology Regulatory Affairs
Vor 4 Tagen
Visp, Schweiz Panda International VollzeitAbout UsPanda International is a leading Contract Manufacturing Organization (CMO) dedicated to delivering high-quality products and services to the biotechnology industry. We are committed to excellence and innovation, and we seek like-minded individuals to join our team.Role Overview:This role offers the opportunity to work in a fast-paced environment with...
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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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Associate Director, Process Analytics
vor 1 Woche
Visp, Schweiz TN Switzerland VollzeitAssociate Director, Process Analytics (HPLC)Technical Operations, Quality & Manufacturing Visp, SwitzerlandDescriptionWe are seeking an Associate Director, Process Analytics, to oversee HPLC applications like test method development, transfer, and validation for the release testing of monoclonal antibodies, fusion proteins, and antibody-biopolymer conjugates...
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Director, Manufacturing
Vor 4 Tagen
Visp, Schweiz Vaxcyte Vollzeit**Join our Mission to Protect Humankind!** Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease,...
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Director Global Quality Compliance
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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Director - Cqv Lead (Sgie)
vor 1 Woche
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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Director, Head Quality Systems
vor 3 Wochen
Visp, Schweiz Lonza Biologics Porriño SLU VollzeitDirector, Head Quality Systems & ComplianceRelocation assistance is available for eligible candidates and their families, if needed.Today, Lonza is a global leader in life sciences operating across five continents. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our...
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Associate Director, Ge Commissioning
Vor 5 Tagen
Visp, Schweiz Lonza VollzeitWe are hiring for a driven Global Engineering CQ Lead Shared Function (Commissioning, Qualification). In this role you will ensure that services and processes meet the regulatory requirements and quality standards.Join our ambitious team and help deliver world-class engineering projects. This is anoutstanding opportunity to contribute to innovative CQ...
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Associate Director, Msat, Proteins
vor 2 Wochen
Visp, Schweiz Vaxcyte Vollzeit**Join our Mission to Protect Humankind!** Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease,...
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Visp, Schweiz Vaxcyte VollzeitVaxcyte's Commitment to ExcellenceWe are a clinical-stage vaccine innovation company that is committed to excellence in all aspects of our work. Our team is dedicated to developing high-fidelity vaccines to protect humankind from the consequences of bacterial diseases.In this role, you will be responsible for providing technical and operational support for...
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Associate Director, MSAT Proteins
vor 1 Tag
Visp, Schweiz Vaxcyte VollzeitVaxcyte: Protecting HumankindWe are a clinical-stage vaccine innovation company that develops high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella.Job OverviewVaxcyte is seeking an...
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Associate Director, GE Commissioning
vor 3 Wochen
Visp, Schweiz Lonza Group Ltd. VollzeitAssociate Director, GE Commissioning & Qualification (CQ) Visp (80-100%) (m/f/d)Apply locations CH - Visp time type Full time posted on Posted 3 Days Ago job requisition id R64057Today, 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...
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Associate Director, MSAT, Proteins
vor 2 Wochen
Visp, Schweiz Vaxcyte VollzeitJoin our Mission to Protect Humankind!Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group...
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Associate Director, MSAT, Proteins
vor 1 Tag
Visp, Schweiz Vaxcyte VollzeitJoin our Mission to Protect HumankindVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group...
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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...
Regulatory Affairs Director
vor 1 Woche
At Lonza, we're committed to excellence in life sciences. As a key member of our team, you'll play a crucial role in shaping our regulatory strategy and driving business growth. As Director, Governance and Cross-functional Lead – Regulatory Affairs, you'll lead a high-impact team focused on delivering a scalable, adaptable, and business-aligned regulatory framework.
Your responsibilities will include:
- Leading a team within a hybrid matrix setup that supports multiple sites and technologies.
- Serving as a regulatory liaison between local teams and regional/global regulatory leadership.
- Collaborating with Regional Regulatory Experts and Leads to implement harmonized regulatory strategies across all locations.
- Providing regulatory input for new business opportunities, mergers, acquisitions, and site expansions.
- Ensuring compliance considerations are integrated early into Growth Project Teams.
- Aligning closely with the Global Regulatory Affairs Lead for Advanced Synthesis and RA leads from other sites to create a scalable regulatory affairs framework.
- Driving process efficiencies that improve speed-to-market while maintaining compliance.
You'll have the opportunity to partner with internal and external stakeholders to prepare high-quality CMC submissions that satisfy critical regulatory criteria set by FDA, EMA, and other significant regulatory bodies. Your expertise will be instrumental in overseeing the regulatory CMC aspects of programs, providing guidance, managing preparation, and ensuring submission of CMC documentation supporting clinical trial applications and marketing submissions.
We're looking for someone with extensive experience (10+ years) in the pharmaceutical and biotechnology industries, specializing in small and midsize molecules, and additional understanding of large molecules. A degree in Regulatory Affairs, Chemistry, Biology, Biochemistry, Pharmacy, or equivalent is required. You'll need exceptional communication and writing skills, fluency in English, and a proactive problem-solving attitude. We value independent, self-motivated individuals who can multi-task, excel in a dynamic, cross-functional matrix environment, and contribute to a team-based culture that relies on collaboration for effective decision-making.
