Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Manager 50 - Basel, Basel-Stadt - gloor&lang AG
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Senior Manager Regulatory Affairs CMC, EMEA
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Ultragenyx Pharmaceutical VollzeitWhy Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't...
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Basel, Basel-Stadt, Schweiz Ultragenyx VollzeitWhy Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go –...
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Basel, Basel-Stadt, Schweiz BeOne Medicines Vollzeit CHF 120'000 - CHF 180'000 pro JahrBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.The Senior Director, Government Affairs & Public...
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Regulatory Contractor
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Barrington James Vollzeit CHF 60'000 - CHF 120'000 pro JahrJob DescriptionRegulatory Contractor – full-time 6 months contract (remote)We are seeking a Regulatory Affairs Contractor to support one of our small biotech clients, including the preparation and submission of initial Marketing Authorization Applications (MAAs).September start dateFully remote, but preference to have candidates based in Spain, Poland or...
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Regulatory Contractor
vor 1 Woche
Basel, Basel-Stadt, Schweiz Barrington James Vollzeit CHF 90'000 - CHF 120'000 pro JahrRegulatory Contractor – full-time 6 months contract (remote)We are seeking a Regulatory Affairs Contractor to support one of our small biotech clients, including the preparation and submission of initial Marketing Authorization Applications (MAAs).September start dateFully remote, but preference to have candidates based in Spain, Poland or Switzerland.Key...
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Basel, Basel-Stadt, Schweiz BeOne Medicines Vollzeit CHF 120'000 - CHF 180'000 pro JahrBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General DescriptionThe Sr. Manager in Global Medical...
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Medical Affairs Cluster Lead LCM
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Mundipharma VollzeitMedical Affairs Cluster Lead LCMLocation: Switzerland / AustriaDepartment: Medical AffairsJob type: PermanentJoin us and make a difference when it matters mostAt Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and...
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Associate Director, Global Regulatory Operations
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Ultragenyx Vollzeit $ 104'000 - $ 130'878 pro JahrWhy Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go –...
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Associate Director, Global Regulatory Operations
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Ultragenyx Pharmaceutical Vollzeit CHF 120'000 - CHF 180'000 pro JahrWhy Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't...
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Senior Global Product Manager
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Medartis Vollzeit CHF 120'000 - CHF 180'000 pro JahrWe are looking for a committed and motivatedSenior Global Product Manager - Elbow & ShoulderYour ResponsibilitiesCollaborate in product development projects as Product Manager for the elbow and shoulder areaDrive the development of new products and the further enhancement of existing onesPrepare market, sales, and turnover analyses, as well as pricing...
Regulatory Affairs Manager 50
vor 2 Wochen
Unser Kunde ist ein pharmazeutisches Familienunternehmen in der Health Care Branche im Grossraum Basel. Der Hauptsitz und Standort in der Schweiz forscht, entwickelt und produziert ein hochwertiges Produkteportfolio. Davon zählen einige Präparate in der Schweiz zu den Marktführern. Die Produkte werden klinisch in enger Zusammenarbeit mit Fachärzten in Klinik und Praxis getestet. In den letzten Jahren sind zudem neue Lizenz-Kooperationen zur OTC-Portfolioerweiterung entstanden.
Ihre Aufgaben:
- Erstellung und Einreichung von Swissmedic Zulassungsanträgen (Alt- und Neuzulassungen, meldepflichtige und genehmigungspflichtige Änderungen, Verlängerungen von Zulassungen etc.)
- Beantwortung von Behördenanfragen (Swissmedic) wie z.B. List of Questions, Auflagen etc. inkl. RHI-Inspektion im Bereich Registrierung
- Kontrolle von Registrierungspendenzen und Sicherstellung, dass Behördenfristen eingehalten werden.
- Koordination der Regulatory Affairs Informationen und Auflagen an die relevanten internen Abteilungen wie Produktion, QK etc.
- Verantwortlich für die korrekte CPNP-Anmeldung im EU-Raum
- Sicherstellung (in Zusammenarbeit mit einem externen Partner), dass unsere Verpackungen der Dermakosmetika Gamme den EU-Normen entspricht.
- Koordination der Registrierung mit externen Partnern für die Türkei sowie div. asiatische Märkte wie z.B. Thailand, Vereinigte Arabische Emirate etc.
Ihr Profil:
- Naturwissenschaftlicher Abschluss in Biologie, Chemie oder Abschluss einer entsprechenden Fachhochschule
- Langjährige Erfahrung im Bereich humanmedizinische Arzneimittelzulassung mit einem entsprechenden Leistungsnachweis, vorzugsweise in einem KMU mit Erfahrungen im Topischen-, Oralen- und/oder Phytobereich
- Exporterfahrung im Bereich Dermokosmetika von Vorteil
- Muttersprache Deutsch sowie fachspezifische Englischkenntnisse
- Exakte, effiziente und selbstständige Arbeitsweise
