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5 Treffer für Junior Regulatory Affairs Associate Jobs
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Schnelle Bewerbung
Mindestens zweijährige Berufserfahrung und praktische Erfahrung im Bereich Regulatory Affairs (Arzneimittel) innerhalb der EU
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Regulatory Affairs Our Regulatory Affairs department ensures that products comply with applicable regulations and standards. * Higher degree and/or experience preferably in a legal, science or engineering discipline, with a health science or biomedical component e.g. HTA, public health, clinical research, regulatory affairs This includes providing strategic input to product developments, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes to ensure continued compliance. * Compilation and international submissions of regulatory dossiers * Development of regulatory assessments and submission strategies * Gathering of regulatory
The Office for Regulatory Relations 'ORR' centrally coordinates and performs day-to-day management of the STA and Statutory audits. The Office for Regulatory Relations is also responsible for the firm's engagement with the ECB. * Identify common feedback themes across all regulatory and audit topics to create synergies & efficiencies, timely remediation of findings, and to take pre-emptive measures to avoid future findings Regulatory engagement and strategy * Own and strengthen the relationship with key regulatory bodies for GSBE (including external regulatory auditors) * Have holistic overview for all regulatory & external audit related matters * Translate the regulatory bodies' requirements and expectations internally and give strat
Regulatory Affairs Our Regulatory Affairs department ensures that products comply with applicable regulations and standards. * Higher degree and/or experience preferably in a legal, science or engineering discipline, with a health science or biomedical component e.g. HTA, public health, clinical research, regulatory affairs * At least 2 years medical device or regulatory affairs work experience is strongly preferred, graduates with any biomedical related experience e.g. in pharmaceutical industries, clinical research or health technology assessment are also welcome - This includes providing strategic input to product developments, obtaining and maintaining product registrations and approvals, communicating with authorities, and monito
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Controllers, Regulatory Policy/Capital, Associate, Frankfurt
Controllers, Regulatory Policy/Capital, Associate, Frankfurt
Goldman Sachs AG MesseTurm
Frankfurt, Germany
Whether assessing the creditworthiness of the firm's counterparties, monitoring market risks associated with trading activities, or offering analytical and regulatory compliance support, our work contributes directly to the firm's success. Are you passionate about financial and regulatory questions? We are looking for a professional to join our team in Frankfurt with the unique opportunity to work across both the Regulatory Reporting and Regulatory Policy functions. The Controllers team in Frankfurt is responsible for ensuring that the financial and regulatory requirements of our German entities are met, in accordance with statutory and firm requirements. The Regulatory Policy function is a specialist unit within Regulatory Controller
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Regulatory Affairs Our Regulatory Affairs department ensures that products comply with applicable regulations and standards. This includes providing strategic input to product developments, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes to ensure continued compliance. * Prepare and submit applications to international regulatory authorities for product and change approvals * Provide regulatory inputs to product development projects * Develop regulatory strategies for changes and new products worldwide * Lead or coordinate regulatory projects, tasks or compliance initiatives * Previous medical device regulatory experience
At least 3 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices Research & Development * Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155) MED-EL Medical Electronics * Innsbruck * Feste Anstellung * Vollzeit - About MED-EL - MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 2,800 employees around the world. RDEA_12502 - Innsbruck, Austria - Professionals Full-Time 38.5 h Permanent - Your Tasks * Coordination and management
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Bearbeitung von Dossier Kapiteln (CMC Teil, CTD) für neue Produkte und/oder zugelassene Produkte sowie von GMP Dokumenten (z.B. Change Control) * Vorbereitung und von interdisziplinären Meetings zu CMC Themen, Teilnahme an Projektgruppensitzungen - Biotest AG * Dreieich * Feste Anstellung * Vollzeit - Gesundheit ist Teamarbeit. So international wie ein Konzern, so persönlich wie ein Mittelständler, das ist die Kultur bei Biotest. Als weltweiter Spezialist für Immunologie und Hämatologie heißt unsere Mission „Leben retten“. Mit innovativen Produkten und richtungsweisender Forschung geben wir chronisch Kranken neue Perspektiven. Motivierte Mitarbeitende sind da ein Muss. Individuelle Förderung und Entwicklungsperspektiven gehören darum zu unserem Alltag. Werden Sie Teil einer 2.300 Mitarbeitenden starken Idee. * Zusammenstellung von Ver
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CORDEN PHARMA GmbH * Plankstadt bei Heidelberg * Feste Anstellung * Vollzeit - CordenPharma ist ein führender Anbieter für die Entwicklung und Herstellung von pharmazeutischen Wirkstoffen (APIs), Hilfsstoffen, Fertigarzneimitteln und Verpackungsaktivitäten mit mehr als 2.600 Mitarbeitenden weltweit. Mit unseren Dienstleistungen unterstützen wir Pharma- und Biotech-Unternehmen bei der Herstellung von Medikamenten mit dem vorrangigen Ziel, das Leben der Menschen zu verbessern. Unser Netzwerk in Europa und den USA bietet flexible und spezialisierte Lösungen auf fünf Technologieplattformen: Peptides, Lipids & Carbohydrates, Injectable, Highly Potent & Oncology; and Small Molecules. Wir sind bestrebt in all diesen Bereichen höchste Qualität zum Wohl der Patienten zu liefern. Am Standort Plankstadt sind wir mit rund 380 Mitarbeitenden spezialisiert auf die Entwicklung und H
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Senior Scientist for the Proteomics Facility (m/f/d)
Senior Scientist for the Proteomics Facility (m/f/d)
Max-Planck-Institut für Biophysik
Frankfurt am Main
Max-Planck-Institut für Biophysik * Frankfurt am Main * Befristeter Vertrag * Vollzeit - The Max Planck Institute of Biophysics is a leading international research institute that uses and develops biophysical, biochemical and computational methods to investigate the structure, dynamics and function of cellular systems at the molecular scale. It has about 200 employees from more than 25 countries and is located on the Campus Riedberg in Frankfurt am Main. Together with the MPI of Brain Research, we operate a joint mass spectrometry lab to develop MS‑based methods for projects at both institutes. In addition to supporting ongoing scientific projects, we also develop, customize and establish new methods and instruments. More information about our work and the wide range of instruments in the joint lab can be found online.
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AGC Biologics GmbH sucht derzeit zur Unterstützung der „Quality Unit“ im Bereich „Quality Assurance Systems“ ab sofort und unbefristet einen Scientist (m/w/d). * Lieferantenqualifizierung, inkl. Auditierung von Lieferanten und Verhandeln von Quality Agreements - AGC Biologics GmbH * Heidelberg * Feste Anstellung * Vollzeit - AGC Biologics, eine hundertprozentige Tochtergesellschaft der Asahi Glass Company (AGC), ist einer der branchenweit führenden CDMOs in Bezug auf Zuverlässigkeit, technische Exzellenz und Qualität – „Right. On Time“. AGC ist ein japanisches Unternehmen mit Sitz in Tokio, das über 50.000 Mitarbeiter in 30 Ländern beschäftigt, mit einem gehandelten Wert von 12 Milliarden Dollar. Mit Einrichtungen in den USA, Japan, Dänemark und Deutschland bietet AGC Biologics voll integrierte biopha
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Schnelle Bewerbung
We are looking for a scientist to join our team (full-time position). ISAR Bioscience GmbH * Planegg * Befristeter Vertrag * Vollzeit - ISAR Bioscience GmbH is a translational research company in Planegg near Munich, supported by the Free State of Bavaria. Our research focuses on (auto-)immune diseases, degenerative diseases of the brain (Alzheimer's) and the heart. We use human induced pluripotent stem cell (iPSC) technologies to develop disease models for the discovery of novel drugs and cell therapies. In doing so, we enter into strategic partnerships with research institutions and industrial companies. Suitable candidates will join a vibrant and growing start-up company that develops the next generation of disease models and cell therapies by editing and differentiating human induced pluripotent stem cells (hiPSC) into relevant cells of interest.
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Business Processes Senior/Principal Consultant for Life Sciences Industries (f/m/d)
Business Processes Senior/Principal Consultant for Life Sciences Industries (f/m/d)
SAP SE
Walldorf, DE, 69190
Your role is focusing on specific requirements for customers in the Life Science, Pharmaceutical and Chemical industry. * Several years of experience in Consulting or Customer Advisory roles, preferably with focus at the Life Sciences Industry, or as a key user for SAP products in a Life Science, Pharma or Chemical company - As the management consultancy of SAP, we are realizing business value for our customers on their IT & business process transformation journey. A major factor for doing so is to identify and fulfil our customers' requirements, both from IT- and business perspective. SAP innovations help more than four hundred thousand customers worldwide work together more efficiently and use business insight more effectively. Originally known for leadership in enterprise resource planning (ERP) software, SAP has evolved to become a market leader in end-to-end busi
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Quality Assurance Manager (m/w/d) Pharma
Quality Assurance Manager (m/w/d) Pharma
FERCHAU – Connecting People and Technologies
Frankfurt am Main
Kontinuierliche Bewertung von nationalen und internationalen Gesetzen und Richtlinien sowie die Umsetzung von Vorgaben der Bereiche des Qualitymanagements in lokale Prozesse - FERCHAU – Connecting People and Technologies * Frankfurt am Main * Feste Anstellung * Vollzeit - Menschen und Technologien verbinden. Den Perfect Match für unsere Kunden gestalten. Immer die richtigen Expert:innen für die jeweilige Herausforderung finden - das ist unser Anspruch bei FERCHAU und dafür suchen wir Sie: als Mitarbeiter:in für einen unserer Kunden. Wir realisieren spannende Projekte für namhafte Kunden in den Bereichen Pharma und Life Science und überzeugen täglich mit fundierter Expertise und fachlichem Know-how. Sie möchten Ihr Potenzial vollständig entfalten können? Wir bieten Ihnen eine Umgebung mit vielfältigen Aufgaben, neuen Herausforderungen und permanenten C
Clinical Research Associate (m/w/d) Research & Development - MED-EL Medical Electronics * Innsbruck * Feste Anstellung * Vollzeit - Über MED-EL - MED-EL ist ein führender Hersteller von innovativen medizinischen Geräten zur Behandlung verschiedener Arten von Hörverlust. Unser breites Produktportfolio bietet Kindern und Erwachsenen in mehr als 140 Ländern eine an ihre spezifischen Bedürfnisse optimal angepasste Hörimplantatlösung. Als international tätiges Unternehmen mit Hauptsitz in Innsbruck beschäftigt MED-EL mehr als 2900 Mitarbeiter*innen weltweit. RDEA_12503 - Innsbruck, Österreich - Fachkräfte Vollzeit 38,5h Unbefristet - Ihre Aufgaben * Verantwortung für die Überwachung der zugewiesenen Studien und der studienrelevanten Dokumentation, einschließlich der Betreuung der Prüfstellen vom Pre-Monitoring bis zum Abschlussbesuch * Sic
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Regulatory Affairs Manager (m/f/d) Pharmaceuticals
Regulatory Affairs Manager (m/f/d) Pharmaceuticals
OmniVision GmbH
Puchheim bei München
Teilweise Home-Office
Regulatory Affairs Manager (m/f/d) * Several years of professional and practical experience in Regulatory Affairs (medicinal products) within the EU * Creation and revision of product information texts (SmPC, PIL, labelling) to implement regulatory changes and/or to adapt texts to the current state of knowledge * Coordination of all regulatory lifecycle management activities in the OmniVision subsidiaries in Austria, Italy, Spain and Switzerland * Monitoring, interpretation and implementation of new regulatory requirements - OmniVision GmbH * Feste Anstellung * Homeoffice möglich,Vollzeit - is an expanding medium-sized ophthalmology company with its headquarters in Germany and locations in Austria, Italy, Spain and Switzerland. In Germany, OmniVision GmbH is one of th
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Senior Scientist (f/m/d) Delivery & Formulation for mRNA Therapeutics & Vaccines
Senior Scientist (f/m/d) Delivery & Formulation for mRNA Therapeutics & Vaccines
CureVac SE
Tübingen bei Stuttgart
Senior Scientist (m/f/d) Delivery & Formulation for mRNA Therapeutics & Vaccines - CureVac SE * Tübingen bei Stuttgart * Feste Anstellung * Vollzeit - Design. Progress. Together. CureVac SE is a global biopharmaceutical company researching and developing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on prophylactic vaccines, innovative cancer immunotherapies and protein-based therapies. Currently, all RNA people are striving to achieve our main goal: To bring multiple best-in-class mRNA drugs to market. To strengthen our team in Tübingen near Stuttgart, we are currently looking to recruit a - The position will involve working as part of an interdisciplinary team with the aim of developing the therapeutic potential of RNA. Within this remit, you will focus on addressing formulation issues related to this class of medicine
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Know-how in retail segment (pharmacies, technology industry, luxury, ecommerce etc.) It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. * Market analysis & evaluation, define go-to-market strategy with Rowa product portfolio, prepare segmentation and target addressable market * Play a key role in financial budgeting and forecasting for your product portfolio - Becton Dickinson * Frankfurt am Main * Feste Anstellung * Vollzeit - BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads
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Schnelle Bewerbung
Ausübung der regulatorischen Funktion des Leiter Qualitätskontrolle im GMP Umfeld * Leitung eines erfahrenen und hochmotivierten Teams in der Analytik und Qualitätskontrolle Apurano Pharmaceuticals GmbH * Warngau * Feste Anstellung * Vollzeit - APURANO ist ein innovatives pharmazeutisches Unternehmen, das mit seiner weltweit patentierten Herstelltechnologie PuranoTec® neuartige Nanowirkstoffe entwickelt. Derzeit führen wir die weltweit größten Phase 3 Studien für unseren Wirkstoff Adezunap im Bereich chronische Schmerzen durch und starten weitere klinische Prüfungen. Ihr Aufgabenbereich * Weiterentwicklung von analytischen Methoden * Erstellung von Zulassungsunterlagen für den Bereich Produktqualität * über ein abgeschlossenes Studium der Chemie, Pharmazie oder Biochemie mit Promotion verfügen. * mindestens 6 Jahre Er
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Schnelle Bewerbung
Wir suchen einen Manager Regulatory Affairs (m/w/d) in Teilzeit (50 %) Neovii Biotech GmbH * Gräfelfing * Feste Anstellung * Teilzeit - Neovii Biotech ist Spezialist für die Entwicklung und Vermarktung von immunologisch wirksamen, biopharmazeutischen Produkten zur Prophylaxe oder Therapie immunologischer Erkrankungen. Der Schwerpunkt liegt auf dem Einsatz innovativer Antikörpertherapien. Neovii Biotech produziert und vermarktet insbesondere einen polyklonalen Antikörper, der in der Transplantationsmedizin etabliert und weltweit in mehr als 40 Ländern zugelassen ist. Ihre Aufgaben * Eine der Hauptaufgaben dieser Stelle ist das Life Cycle Management unserer bestehenden nationalen Zulassungen sowie die Einreichung unseres Dossiers in Ländern, in denen unser Produkt noch nicht zugelassen ist. * Sie halten engen Kontakt zu unseren internationalen Partnern
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Scientific Consultant (m/f/d) in Quantum Computing Start-Up
Scientific Consultant (m/f/d) in Quantum Computing Start-Up
Kipu Quantum GmbH
Berlin, Karlsruhe
Teilweise Home-Office
Engage in scientific research and development to enhance quantum computing applications * Familiarity with scientific computing and scalable database systems, cloud computing, and API development - Kipu Quantum GmbH * Berlin, Karlsruhe * Feste Anstellung * Homeoffice möglich,Vollzeit - About - Kipu Quantum is a German startup focused on quantum computing, with offices in Karlsruhe and Berlin. We specialize in developing quantum algorithms tailored for specific applications and hardware. Our solutions help various industries, including pharmaceuticals, chemicals, logistics, and finance, to tackle complex problems using existing quantum hardware. We aim to make practical quantum computing accessible by significantly reducing the time needed to achieve quantum advantage for real-world applications. In December 2023, Kipu Quantum secured
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Several years working experience in regulatory affairs /product safety - You will coordinate the activities of our European subsidiaries in the areas of product stewardship, including compliance with chemical and other product regulations, supply chain communication, advocacy in regulatory development, and represents the product stewardship and regulatory interests of the businesses in Europe. In this position you will advise and harmonize regulatory on European level and coordinates regulatory activities. * Focus on future regulatory developments * Monitor and report regulatory developments, give guidance to and coordinate activities with our areas of product safety section * Develop regulatory strategies and impleme
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die Optimierung von globalen standortübergreifenden Regulatory Affairs Prozessen vorantreiben * umfangreiche Erfahrung im Bereich Regulatory Affairs in der Medizintechnik oder vergleichbare Berufserfahrung * als Ansprechpartner für interne Bereiche (R&D, Projektleitung, Produktmanagement, Marketing Communications, Clinical Affairs, internationalen RA Ansprechpartner/innen in den jeweiligen Märkten) sowie extern für Partner und Behörden auftreten * Oberkochen (Baden-Württemberg) * Feste Anstellung * Vollzeit - Sich etwas Neues trauen, über sich hinauswachsen und dabei die Grenzen des Machbaren neu definieren. Genau das ist es, was unsere Mitarbeitenden täglich leben dürfen und sollen. Um mit unseren Innovationen das Tempo vorzugeben und Großartiges zu ermöglichen. Denn hinter jedem erfo
Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure successful documentation and validation of systems according to internal procedures * Maintain validation documentation, review the risk assessments for new and existing computerized systems * Conduct periodic reviews and trigger the re-validation of systems as required * Stay current with industry trends, regulatory changes, and best practices in computerized system validation * Previous work experience in Computerized System Validation within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices) would be an advantage - MED-EL Medical Electronics * Innsbruck * Befristeter Vertrag * Vollzeit - About MED-EL - MED-EL is a leading manufacturer of innovative medical dev
Support of our subsidiaries, , clinics and patients worldwide * Technical support for and comprehensive knowledge of the middle ear implant (VIBRANT SOUNDBRIDGE) and the bone conduction solutions (BONEBRIDGE and ADHEAR) * Technical understanding especially when it comes to online activities like training and remote support MED-EL Medical Electronics * Innsbruck * Feste Anstellung * Homeoffice möglich,Vollzeit - About MED-EL - MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 2,800 employees around the world. VCS_12501 - Innsbruck, Austria - Professionals Full-Tim