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Associate Manager Regulatory Affairs

Req #: 1800800
Location: Zürich, Zurich CH
Job Category: Regulatory Affairs
Work Location: Bändliweg 20, Postfach ZURICH 8048
Organization: Celgene Gmbh
Schedule: 40
Employee Status: Full time
Job Type: Regular
Job Level:
Other Locations:Switzerland- Zurich


Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities include, but are not limited to:

  • Responsible for the maintenance of current MAA’s for the assigned products
    • acts as main contact towards Swiss HA for the assigned products
    • meeting time schedules and demands of authorities for updates, variations, periodic regulatory reports (e.g. PSURs), renewal of valid registrations
  • Defines the regulatory strategy for Celgene products in Switzerland with the support of the Local Regulatory Affairs lead
    • develops submission strategies for NAS application and major variations
    •  monitors changes in guidelines and flags chances and risks to the team 
  • Close collaboration with the European Regulatory Head Quarter and Reg. Operation
    • defines content and timelines for submission
    • gives guidance to global project teams on Swiss regulations
    • assures proper timeline management according to CH requirements 
  • Represents Regulatory Affairs within the local, interdisciplinary Disease Teams for the assigned portfolio
    • drives strategic development from a regulatory affairs perspective
    • Builds strong knowledge and network in the relevant disease area’s
  • 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
  • Strong negotiation skills.
  • Strong written and verbal skills in German and English
  • Good computer skills to include: MS Office incl. MS Project
  • Strong identification with Celgene’s values

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About Celgene

Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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