Quality & Regulatory Associate, Challenging Global Role, Basel
Vor 5 Tagen
An ambitious forward thinking Dermatology company based in the centre of Basel have created an exciting hybrid QARA Associate opportunity that will work closely with the International QARA Director in managing the company's global QA and RA functions.
This is a highly successful company who have an impressive 200% year on year growth and are going through significant expansion. They currently have 8 products on the market but have a further 5 more products in development, one of which will be released early next year.
Tasks:
Creation, compliance and/or implementation of SOP, Work Instructions, Non-Conformities, Change Control, CAPA, Artworks, and all related document and tasks. Maintain and update all the documents in the companies system. Provide support for Internal and External Audit. Initiate and review regulatory documents ( Technical file) giving support to the Regulatory Manager with the transition from MDD to MDR. Coordinate worldwide registration and compile regulatory submissions, including required legalization activities. Liaise with local agents and distributors to support them in their registration process. Maintain regulatory records and regulatory database.Requirements
3 plus year's experience in a similar role. Strong knowledge of regulatory regulations and Quality Systems including knowledge of ISO13485, MDD, MDR and MDSAP requirements in link with QMS activities. Experience of the Medical Device or Pharmaceutical industry. Proactive self-starter who can work autonomously. Strong communication skills with the ability to liaise effectively with stakeholders, suppliers and distributors. Fluent in written and spoken English essential, Spanish an advantage.Benefits
-
Global Quality Leader
vor 1 Tag
Basel, Basel-Stadt, Schweiz Cpl Life Sciences Switzerland VollzeitJob DescriptionCpl Life Sciences Switzerland is seeking an experienced Quality Assurance Strategist to drive the implementation and alignment of global R&D quality strategies across international and affiliate operations.This role ensures that local teams maintain strong, efficient, and compliant Quality Management Systems (QMS) tailored to both global...
-
Regulatory Affairs Specialist Role
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Skilled Recruitment Solutions GmbH VollzeitJob Overview:">Skilled Recruitment Solutions GmbH is seeking a Clinical Scientist to support the development of clinical trials within the pharmaceutical industry.">This role requires a strong background in clinical research, with experience in protocol development, data review, and medical monitoring.">The successful candidate will work closely with...
-
Senior Regulatory Professional
vor 3 Stunden
Basel, Basel-Stadt, Schweiz Proclinical Staffing VollzeitSenior Regulatory ProfessionalWe are seeking a highly experienced Senior Regulatory Professional to join our team in Basel, Switzerland. In this role, you will be responsible for ensuring compliance with regulatory requirements and best practices within the cardiovascular pharmaceuticals industry.The ideal candidate will have a strong background in quality...
-
Global Quality Operations Manager
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Lonza VollzeitLonza, a global leader in life sciences, is seeking an experienced professional to fill the role of Global Head of Quality Operations, Biologics. This position plays a crucial part in ensuring the quality and regulatory compliance of our biologics products across various sites.The successful candidate will be responsible for providing technical expertise and...
-
Quality Assurance Manager
vor 5 Stunden
Basel, Basel-Stadt, Schweiz Proclinical Staffing VollzeitDirect message the job poster from Proclinical StaffingSenior Research Associate @ Proclinical StaffingProclinical is seeking a Quality Assurance Manager to join our client's team in Basel, Switzerland. This role focuses on ensuring compliance with regulatory requirements and best practices within the cardiovascular pharmaceuticals industry. You will play a...
-
Associate Director GCP Quality Systems
vor 1 Tag
Basel, Basel-Stadt, Schweiz Cpl Life Sciences Switzerland VollzeitOur client is seeking an experienced quality leader to drive the implementation and alignment of global R&D quality strategies across international and affiliate operations. This role ensures that local teams maintain strong, efficient, and compliant Quality Management Systems (QMS) tailored to both global expectations and regional regulatory...
-
Regulatory Affairs Manager Small Molecules
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Lonza VollzeitCompany OverviewLonza is a global leader in life sciences operating across three continents. We work in science, where talented people devise ideas that help businesses improve lives. In exchange, we let our people own their careers, driving meaningful progress in various industries.Job DescriptionWe are looking for an Associate Director, Regulatory Affairs...
-
Director of Pharmaceutical Quality
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Lonza VollzeitLonza is a global leader in life sciences, and we are committed to delivering high-quality products and services to our customers. In this role, you will play a critical part in ensuring the quality and regulatory compliance of our biologics products.The Global Head of Quality Operations, Biologics will be responsible for providing technical expertise and...
-
Basel, Basel-Stadt, 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,...
-
Regulatory Affairs Executive
vor 3 Stunden
Basel, Basel-Stadt, Schweiz Proclinical Staffing VollzeitQuality Management ExpertWe are seeking a highly experienced Quality Management Expert to join our team in Basel, Switzerland. In this role, you will be responsible for ensuring compliance with regulatory requirements and best practices within the cardiovascular pharmaceuticals industry.The ideal candidate will have a strong background in quality management,...
-
Head of Regulatory Compliance Small Molecules
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Lonza VollzeitAbout UsLonza is a global company that harnesses the power of science to create innovative solutions for businesses and people around the world. Our expertise in life sciences drives meaningful progress in various industries.Job SummaryWe seek an Associate Director, Regulatory Affairs Small Molecules to provide strategic guidance and regulatory support to...
-
Quality Assurance Lead
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Bechtle Schweiz AG, Onsite Services VollzeitA seasoned professional is sought for a challenging role as a GxP Audit Manager in Basel.This critical position involves developing and implementing effective audit strategies, managing internal and external audits, and ensuring compliance with relevant standards.ResponsibilitiesDevelop and implement risk-based audit strategies that meet global standardsLead...
-
Global Regulatory Expert
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitWe believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Join our community where you can show up as yourself, embraced for the unique qualities you bring.About this ChapterThe PD Regulatory Program Management Chapter is accountable and responsible for...
-
Global Quality Enablement Lead
vor 1 Tag
Basel, Basel-Stadt, Schweiz Lonza Biologics Porriño SLU VollzeitJoin Our Team as a Global Quality ExpertWe're a leading biotechnology company, committed to improving lives through innovative solutions. Our talented professionals drive groundbreaking research and development.In this role, you'll work closely with the Senior Vice President, Global Quality, to drive strategic priorities and operational excellence.You will...
-
Global Regulatory Specialist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitAbout the Role:Candidate Requirements: To be successful in this Senior Global Labeling Manager position, applicants should possess relevant work experience in global labeling or regulatory affairs/pharmaceuticals. A strong understanding of regulatory guidelines and medical terminology is essential. In addition, proficiency in English (and additional...
-
Pharmaceutical Quality Manager
vor 3 Stunden
Basel, Basel-Stadt, Schweiz Proclinical Staffing VollzeitJob SummaryWe are seeking a skilled Pharmaceutical Quality Manager to join our team in Basel, Switzerland. As a key member of the quality management team, you will be responsible for ensuring compliance with regulatory requirements and best practices within the cardiovascular pharmaceuticals industry.The ideal candidate will have a strong background in...
-
Basel, Basel-Stadt, 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,...
-
Senior Director Regulatory Strategy
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Lonza VollzeitOur StoryLonza has a long history of innovation and dedication to improving lives worldwide. We harness the power of science to create innovative solutions for businesses and people around the world.Job DescriptionWe are seeking an Associate Director, Regulatory Affairs Small Molecules to join our team. This role offers the opportunity to work on challenging...
-
Global Quality Assurance Lead
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Sobi - Swedish Orphan Biovitrum AB (publ) VollzeitAbout the RoleThe Quality Supplier Manager will play a critical role in ensuring the quality of our products and services. This includes developing and maintaining quality systems, processes, and procedures to ensure compliance with regulatory requirements.You will work closely with internal stakeholders to identify and mitigate quality risks, develop...
-
Quality Assurance Expert
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz CTC VollzeitJob Description:The Service Center Specialist plays a pivotal role in ensuring the highest standards of product and service quality, regulatory compliance, and continuous improvement. As a key member of the Global Quality team, this individual will be responsible for coordinating global vendor change notifications, including communication with all parties...