Regulatory Affairs Manager
vor 1 Woche
The Europe & Canada (EUCAN) Business unit supports Takeda's mission at a regional level and as the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people.
Across the EUCAN BU, patients come first in every decision we make. We develop strategic partnerships which deliver value for society and create a culture within which our people can thrive and reach their full potential.
Our mission is to empower and enable our people to fulfill their potential by embracing diversity and creating a high-performance, collaborative working environment. In the EUCAN region integrity is one of our key values. We put patients, trust and reputation before business and this is one of the main reasons why our people choose to work here.
**Job ID** R0121208**Date posted** 04/19/2024**Location** Zurich, Canton of Zurich**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have?
**We are currently hiring for a Regulatory Affairs Manager**
**(all genders) in full-time on a permanent contract for our Swiss local office in Glattpark (Opfikon).**:
**Your tasks in detail**:
- Manage **MA lifecycle maintenance** for a defined product portfolio, inclusive local impact assessments of global changes, preparation, and filing of renewals, variations (CMC and non-CMC), labeling updates, PSUR/PBRERs etc. to ensure national registrations and comply with Swiss local requirements.
- Ensure **compliance of labelling** (and mock-ups) with the CCDSs and manage communication to internal and external stakeholders as applicable to ensure timely implementation
- Contact for the assigned products towards Swissmedic and respond within required Deadlines to Swiss Authorities
- Represent Regulatory Affairs for the defined product portfolio in internal cross-functional meetings and projects
- Support QA department for product releases
- Maintain **global and local regulatory databases** and systems to ensure accurate records of regulatory activities and documentation
- Review **promotional and educational materials** for the assigned product portfolio
- Contribute to Regulatory Intelligence and assess impact on local business and products
**Your profile**:
- University degree in Pharmacy or other scientific studies
- Minimum 2 years’ experience in Regulatory Affairs, within a pharmaceutical company. CRO, similar organization in Switzerland or Swissmedic
- Advanced knowledge of applicable Swiss laws, regulations, and codices for pharmaceutical industry in Switzerland
- Business fluency in German and English (speaking and writing)
- Cross-functional mindset: Strong communicator with the ability to engage both external and internal customers
**Desirable additional skills**:
- Additional national language is a plus (French/ Italian)
**Empowering our people to shine**
**Diversity, Equity and Inclusion**
**Locations**: CHE - Glattpark (Opfikon) - Zurich HQ
- ** Worker Type**: Employee
- ** Worker Sub-Type**: Regular
- ** Time Type**: Full time
-
Regulatory Affairs Manager
Vor 4 Tagen
Zurich, Schweiz Sonova VollzeitWho we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...
-
Regulatory Affairs Manager/in
vor 2 Monaten
Zurich, Schweiz Skilled- Recruitment Solutions Vollzeit**Aufgaben**: - Qualitäts - und zulassungsrelevante Dokumenten erstellen, überprüfen und pflegen - Zulassungsdossiers während des gesamten Lebenszyklus pflegen sowie die unterstützende Mitwirkung bei internen Optimierungsprojekten für kommerzielle Produkte - Dokumente zusammenstellen, Projektleistungen für die Registrierungsvorbereitung sowie die...
-
Regulatory Affairs Manager
vor 4 Wochen
Zurich, Schweiz LHH VollzeitFür unseren Mandanten mit Niederlassung im Grossraum Zürich suchen wir einen **Regulatory Affairs Manager (m/w/d)**. Ein familiärer Umgang und eine täglich gelebte Wertschätzung zeichnen das Unternehmen aus. Aufgabengebiet - Mitarbeit in Projektteams und Schnittstelle zu anderen Fachabteilungen hinsichtlich der regulatorischen Anforderungen bei der...
-
Regulatory Affairs Manager
vor 1 Woche
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...
-
Regulatory Affairs Cmc Manager
vor 2 Monaten
Zurich, Schweiz CSL Behring VollzeitCSL Vifor is a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company. We are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis. - Effectively collaborate with technical experts, oversee and direct compilation and update of CMC related dossier components,...
-
Regulatory Affairs Manager
vor 3 Wochen
Zurich, Schweiz Pfizer VollzeitRegulatory Affairs Manager (M/F/d) time type: 60%/80%/100% This is what you can look forward to: - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background - Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. - Developing...
-
Regulatory Affairs Coordinator
vor 2 Monaten
Zurich, Schweiz Pfizer VollzeitWeltweit arbeiten die Mitarbeiter von Pfizer gemeinsam daran, die Gesundheit eines jeden Einzelnen überall zu verbessern. Während wir Arzneimittel und Medizin-Produkte entwickeln und unser Geschäft global ausweiten, halten wir jederzeit Ausschau nach neuen Talenten. Derzeit suchen wir Sie an unserem Standort in Zürich als: Regulatory Affairs Coordinator...
-
Global Regulatory Affairs Labelling Manager
vor 2 Wochen
Zurich, Schweiz CSL Behring VollzeitCSL Vifor is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent global position in the Global Regulatory Affairs Labelling team has arisen. Which can be based at any of our CSL R&D Hubs (Maidenhead UK, Amsterdam, NL, Bern, CH, Zurich, CH, KOP, PA or Waltham,...
-
Regulatory Affairs Manager
vor 4 Wochen
Zurich, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Head Regulatory Affairs Emerging Markets
vor 3 Wochen
Zurich, Schweiz ARIAD Vollzeit**Job ID** R0098443**Date posted** 06/16/2023**Location** Zurich, Canton of Zurich**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic...
-
Head Regulatory Affairs Emerging Markets
vor 3 Wochen
Zurich, Schweiz ARIAD Vollzeit**Job ID** R0098443**Date posted** 06/16/2023**Location** Zurich, Canton of Zurich**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic...
-
Head Regulatory Affairs Emerging Markets
vor 1 Woche
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic and visionary leader with a strong background in regulatory affairs within the...
-
Regulatory Affairs Manager
vor 3 Wochen
Zurich, Schweiz Takeda Pharmaceutical Vollzeit**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...
-
Director Regulatory Affairs
vor 2 Monaten
Zurich, Schweiz Sonova VollzeitWho we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...
-
Director, Global Regulatory Affairs Cmc
vor 4 Wochen
Zurich, Schweiz Takeda Pharmaceutical VollzeitJoin Takeda as a Director, Global Regulatory Affairs (GRA) CMC, where you will lead GRA CMC Due Diligence in partnership with organizational and external stakeholders. You will ensure the communication/development of regulatory CMC risks and strategy, develop best practices that enable CMC due diligence, ensuring that a given compound meets technical and...
-
Manager Regulatory Affairs 80
vor 1 Woche
Zurich, Schweiz Adecco VollzeitFür unseren Kunden, ein Unternehmen im Bereich der medizinal-technischen Produktherstellung, suchen wir zum nächst möglichen Zeitpunkt, eine*n **Manager*in Regulatory Affairs 80 - 100 % (w/m/d)** **Ihre Aufgaben** - In der abwechslungsreichen Position als Manager Regulatory Affairs verantwortest Du das Tagesgeschäft im Bereich Regulatory Affairs für...
-
Regulatory Affairs
vor 2 Wochen
Zurich, Schweiz Proclinical VollzeitOur client a global pharmaceutical company specializing in rare diseases, Nephrology and Cardiorenal therapeutic areas is looking to appoint a Regulatory Affairs Labelling manager in their Zurich offices. This is an excellent opportunity to gain global experience within RA labelling in a high performing team at a time when multiple new drug development...
-
Regulatory Affairs Manager Pharma Eu/ch
vor 2 Wochen
Zurich, Schweiz Bernwald Personalberatung VollzeitUnsere Mandantin ist ein Schweizer KMU, das sich in einer Nische im Pharmabereich erfolgreich etabliert hat. - In ihrem Auftrag suchen wir eine Persönlichkeit mit ausgeprägtem Verantwortungsbewusstsein als Regulatory Affairs Manager Pharma EU/CH (m/w/d). **IHRE AUFGABEN**: - Selbständiges Erstellen von CMC-Zulassungsdokumentationen - Termingerechte...
-
Regulatory Affairs Spezialist 80%
vor 1 Woche
Zurich, Schweiz Adecco VollzeitWir suchen derzeit einen Regulatory Affairs Spezialisten, um dem angesehenen Team unseres Kunden im Kanton Zürich, Schweiz, beizutreten. Der ideale Kandidat verfügt über fundierte Kenntnisse im Bereich der pharmazeutischen oder chemischen Regulatory Affairs sowie über außergewöhnliche Kommunikationsfähigkeiten und ein Engagement für...
-
Regulatory Affairs Manager
vor 2 Wochen
Zurich, Schweiz Pfizer VollzeitRegulatory Affairs Manager (M/F/d) 80-100% This is what you can look forward to: - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background - Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. - Developing of submission...
