Global Regulatory Affairs Clinical Solutions
vor 5 Stunden
-CSL 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. A position has arisen within the Global Regulatory Affairs function in our Clinical Solutions Team for Manager to focus on clinical support of development compounds across the whole Vifor Pharma portfolio.
You will support regulatory product strategy development teams to evaluate and execute clinical regulatory strategies and protocols to achieve business objectives, approvals and optimal labels as well and maintain current regulatory and clinical intelligence with respect to the changing landscape of clinical development strategies
Working cross functionally internally (clin ops, clin development, therapeutic RA, labelling etc) and with external partners and providing vendor (CRO) oversight as well as CSL Vifor Clinical Study teams.
We are looking for a seasoned individual from CRO or sponsor side who has demonstrable expertise of the above with exceptional communication and stakeholder management skills.
Key Measurements of Success
- Demonstration of timely and proactive information of GRA Product Strategy leads and product RAFT of relevant clinical activities
- Successful demonstration of support for key design elements of CSL VIFOR sponsored clinical studies
- Effective collaboration with relevant functions and teams within the company and affiliates on clinical matters
- Successful demonstration of GRA compliance with CSL VIFOR and external standards related to GCP as evidenced through audits, inspections and Clinical Study team (CST) reviews
- Regulatory documents are inserted in Trial Master Files (TMFs) and available for end of trial audit for trials within the designated area of responsibility
- Clinical trials details and data for CSL VIFOR activities maintain on clinical transparency sites in accordance with internal procedures and regulatory requirements
- Demonstration of timely maintenance of clinical submissions (monitoring and archiving) on relevant GRA IT systems
- Understanding of relevant Health Authority clinical regulations, guidance, procedural requirements and data transparency
**Responsibilities**:
- Support GRA Clinical Study Teams (CST) members in the development and monitoring of long & short-term product regulatory planning related to the set-up, conduct, and completion of clinical trials.
- Act as primary representative for GRA on assigned CSTs and as deputy/back-up for GRA CST member as appropriate
- Support GRA Product Strategy Leads and Regulatory Affairs Functional Teams (RATFs) with the coordination and preparation and global submission oversight of clinical submissions to Health Authorities.
- Support GRA CST members in the auditing and records management for the regulatory sections of clinical trial master files,
- Monitor submission procedures (Health Authorities) and archive submissions using the relevant GRA IT systems
- Support the setting up and the completion of global transparency strategies for assigned clinical trials, oversee posting of synopsis and study results on relevant international registers (EUDRACT, CT.gov)
- Represent GRA on cross-functional initiatives related to clinical processes, e.g. CMRS QA GCP compliance initiatives, GCP related audits & inspections, CMRS clinical PDs and documentation systems.
- Support development of CSL Vifor cross-functional R&D clinical procedures, and for organizational structure and systems related to clinical research.
- Monitor national and international registration requirements through reviews of websites, publications, seminars, and similar sources, and communicate requirements to GRA staff.
**Requirements**:
Minimum Requirements
- University degree, preferably in pharmaceutical or health related field
- 4 - 8 years’ experience in clinical development or regulatory affairs in the pharmaceutical industry (prescription drugs)
- Proven, first-hand experience of working in a fast-paced team environment
- Experience in working in a multinational regulatory affairs environment within the pharmaceutical industry
- Familiarity with the global regulatory environment and GCP regulations
- Familiarity with CTA/IND processes to support multinational clinical trials
- Good computer skills, including proficiency with MS Office (including Word and PowerPoint)
Other Preferred Requirements
- Experience with eDMS, records management, or catalogue database systems
Languages:
- Professional in English (oral and in writing)
- Proficiency in German or French an advantage
**About Us**:
-
Pharmacovigilance Quality Management Lead
Vor 6 Tagen
Glattbrugg, Schweiz Vifor Pharma VollzeitVifor Pharma is experiencing rapid pipeline optimization and growth in Nephrology, Cardio-Renal and Rare diseases. A position has arisen in the Pharmacovigilance Quality Assurance (GPvP) group in a leadership role to manage a talented team of PV Quality Auditors and take responsibility for all PV Quality Assurance related topics within the wider Clinical and...
-
Drug Safety Lead Cardio Renal Product
Vor 3 Tagen
Glattbrugg, Schweiz Vifor Pharma VollzeitWe are currently looking for a Drug Safety Lead to join our Global Drug Safety and Risk Management Team. Reporting directly to the Therapeutic Area Lead of Medical and Clinical Drug Safety, you will be responsible to ensure compliance of company drug safety. Your tasks and responsibilities will include, but not be limited to, the following: - Manage the...
-
Medical Information Manager
vor 7 Monaten
Glattbrugg, Schweiz Coopers Group AG VollzeitMedical Information Manager For our client, a leading company in the Pharmaceutical Industry, we are currently looking for a** Medical Information Manager** **Background**: Management of medical information content in alignment with the product life-cycle and regulatory milestones and leveraging the global medical information content strategy...
-
Pricing Lead for The Global Value, Access
Vor 3 Tagen
Glattbrugg, Schweiz Vifor Pharma VollzeitCSL Vifor, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, is experiencing rapid growth due to pipeline realization and optimization. We are recruiting for an accomplished Global Pricing Lead to take an immediate assignment in our global value, access and policy team based in Zurich. This role represents a unique...
-
Head of Toxicology
vor 2 Wochen
Glattbrugg, Schweiz Vifor Pharma VollzeitVifor Pharma a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company are experiencing rapid growth due to pipeline realization and optimization. At this time, we look to appoint a Head of Toxicology within our Research and Non-clinical group. Reporting to the Head of Research and Non-clinical Development you will lead an...
-
Researcher: Health Technology
vor 1 Tag
Glattbrugg, Schweiz Ouroboros Solutions VollzeitLocation: Ouroboros Solutions | Zürich-Glattbrugg Hiring date: nach Vereinbarung Employment contract type: Unlimited Reference number: 28454 As the largest medical network in Switzerland, we set standards with our clinics, outpatient surgery centres and emergency units. First-class medical quality and the well-being of the individual are our focus. -...
-
Advisory Presales Solution Consultant
vor 7 Monaten
Glattbrugg, Schweiz ServiceNow Vollzeit**Company Description** At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for our customers and communities. By joining ServiceNow, you are part of an ambitious team of change makers who have a restless curiosity and a drive...
-
Scientific Director
vor 1 Woche
Glattbrugg, Schweiz Vifor Pharma VollzeitVifor Pharma 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. At this time we are seeking to appoint a scientific director within our nanomedicines group You will provide scientific input for...
-
Global Medical Information and Library Services
Vor 2 Tagen
Glattbrugg, Schweiz Vifor Pharma VollzeitCSL Vifor, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company are experiencing rapid growth due to pipeline realization, optimization and global partnership alliances. As such the need has arisen for a Global Medical Information and Library Services Manager based in our Headquarters in Glattbrugg, Switzerland. In this global...
-
(Senior) Market Access Manager
vor 2 Monaten
Glattbrugg, Schweiz Otsuka Pharma GmbH VollzeitAufgaben:Mitwirkung bei der Initiierung, Umsetzung und Koordination von Maßnahmen für den optimalen Marktzugang insbesondere in Hinblick auf Market Access Strategien und -Pläne.Unterstützung bei der Vorbereitung und Koordination des AMNOG-Prozesses sowie bei der Erstellung des Nutzendossiers in Zusammenarbeit mit einem externen Dienstleister.Initiierung...
-
Solution Designer
vor 1 Woche
Glattbrugg, Schweiz SPS Holding AG VollzeitWIR VERBINDEN DIE PHYSISCHE UND DIE DIGITALE WELT - SPS ist der führende Outsourcing-Anbieter von innovativen Dienstleistungen in Geschäftsprozessen und Datenmanagement. Schweizer Qualität gepaart mit globaler Präsenz machen SPS zum verlässlichen Partner für Prozessoptimierung und intelligenter Automatisierung. Mit unseren ganzheitlichen Lösungen...
-
Sr Solution Consultant
vor 7 Monaten
Glattbrugg, Schweiz ServiceNow Vollzeit**Company Description** At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for our customers and communities. By joining ServiceNow, you are part of an ambitious team of change makers who have a restless curiosity and a drive...
-
Global Brand Team Lead
vor 3 Wochen
Glattbrugg, Schweiz Vifor Pharma VollzeitVifor pharma is experiencing rapid growth due to pipeline acceleration and launch of a rare disease product within vasculitis. As such, a unique opportunity has arisen to take a seat in our Global Headquarters in Glattbrugg, as the Global Brand Team Lead for our latest rare disease product. In this role you will be responsible for leading the brand...
-
(Senior) Market Access Manager DACH
vor 2 Monaten
Glattbrugg, Schweiz Otsuka Pharmaceutical (Switzerland) GmbH VollzeitDeine Aufgaben:Mitwirkung bei der Initiierung, Umsetzung und Koordination von Maßnahmen für den optimalen Marktzugang insbesondere in Hinblick auf Market Access Strategien und -PläneUnterstützung bei der Vorbereitung und Koordination des AMNOG-Prozesses sowie bei der Erstellung des Nutzendossiers in Zusammenarbeit mit einem externen...
-
(Senior) Market Access Manager DACH
vor 1 Monat
Glattbrugg, Schweiz Otsuka Pharmaceutical (Switzerland) GmbH VollzeitDeine Aufgaben:Mitwirkung bei der Initiierung, Umsetzung und Koordination von Maßnahmen für den optimalen Marktzugang insbesondere in Hinblick auf Market Access Strategien und -PläneUnterstützung bei der Vorbereitung und Koordination des AMNOG-Prozesses sowie bei der Erstellung des Nutzendossiers in Zusammenarbeit mit einem externen...
-
Advisory Solution Consultant/ Presales
Vor 6 Tagen
Glattbrugg, Schweiz ServiceNow Vollzeit**Company Description** At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for our customers and communities. By joining ServiceNow, you are part of an ambitious team of change makers who have a restless curiosity and a drive...
-
Team Assistant, Global Partner Business
vor 1 Woche
Glattbrugg, Schweiz Vifor Pharma VollzeitVifor Pharma is currently looking for a Team Assistant to the Head of Global Partner Business. The role is based in Glattbrugg. You will effectively support the Head of Global Partner Business and the HQ Partner Business team in administrative tasks, organization and coordination of activities. You will manage communication between senior executives and...
-
2025 Graduate Talent Program
vor 1 Woche
Glattbrugg, Schweiz UBS Vollzeit2025 Graduate Talent Program - IB Global Markets FX Structuring **Your role** Interested in working in financial services, specifically learning about OTC derivatives and structured products, but not sure where to start? Do you want to work for a firm with a truly global footprint? We're looking for ambitious students to join our 2025 Global Markets...
-
Sr Solution Consultant
vor 7 Monaten
Glattbrugg, Schweiz ServiceNow Vollzeit**Company Description** At ServiceNow, our technology makes the world work for everyone, and our people make it possible. We move fast because the world can’t wait, and we innovate in ways no one else can for our customers and communities. By joining ServiceNow, you are part of an ambitious team of change makers who have a restless curiosity and a drive...
-
Portfolio Solutions Underwriter PI
vor 1 Woche
Glattbrugg, Schweiz American International Group VollzeitPortfolio Solutions Underwriter PI & Cyber (w/m/d)Location: GlattbruggTime Type: Full timePosted: 30+ Days AgoJob Requisition ID: JR2402926Seit über 100 Jahren führend – AIG ist als weltweit agierendes Versicherungsunternehmen auf die Absicherung komplexer und ungewöhnlicher Risiken spezialisiert. Multinationale Konzerne, lokale Unternehmen und...
