Job Detail

Req #: 1903138


Location: Zurich, Zurich, Switzerland


Job Category: Regulatory Affairs


Work Location: Bändliweg 20, Postfach 8048


Organization: Regulatory Affairs


Employee Status: Full-time


Job Type: Fixed_Term

Celgene is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we’re looking for talented professionals like you to join our team. What unique gene will you bring to Celgene?

Responsibilities include, but are not limited to:

• Support the RA Team in the maintenance of current market authorizations:
  
  
  
  • meeting time schedules and demands of authorities for updates,
  
  
  • prepares and submits variations
  
  
  • prepares and submits periodic regulatory reports (e.g. PSURs)
  
  
  • prepares and submits renewal of valid registrations
  
  
  • interacts with the local disease teams to align LCM
  
  
  • responsible for data and documentation management
  
  

• Supports the Local Regulatory Affairs Team in defining the regulatory strategy for Celgene products in Switzerland


• Supports the local Regulatory Affairs Team in filling major variations and new marketing authorization applications


• Supports the local RP (FvP) and QA Team as needed


• Other activities
  
  
  
  • Engages in inter-department projects
  
  
  • Supports and collaborates with local RMP responsible person
  
  
  • Supports audits and inspections
  
  

Skills / Knowledge Required:

• Excellent project planning, administrative and organizational skills; attention to detail and timelines


• Ability to prioritize tasks, to work on multiple tasks in parallel and under time pressure


• Flexible and adaptable to changing project priorities and work assignments


• Good oral and written communication skills


• Strong written and verbal skills in German and English communication skills


• Good computer skills to include: MS Office incl. MS Project

About Us




COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE



At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.




"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."



There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.