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Chemist, Pharmacist, Biologist, Biotechnologist as Regulatory Affairs Manager - Biosimilars (m/f)

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Regulatory Affairs Manager Biosimilars (m/f) Regulatory Affairs Biopharmaceuticals, Sandoz GmbH, Kundl

Area of Responsibility

  • Independent and timely compilation/preparation of high quality regulatory documentation for complex global regulatory submissions in various countries
  • Liaise with Regulatory Authorities
  • Provide regulatory input and support of development projects of biopharmaceutical products
  • Prepare responses to health authority questions during development, registration, and product lifecycle
  • Responsibility to ensure working compliance with the respective regulations

Qualifications

  • Education: University degree (PhD or alternatively Master with min 4 years relevant professional experience) in Chemistry, Pharmacy, Biology, Biotechnology or a similar education, further education in Regulatory Affairs desirable
  • Languages: English (fluent) / German (basics)
  • Experience: Working experience in the pharmaceutical industry, ideally with quality parts of registration documents desirable
Our salary packages are competitive and take individual qualifications and experience into consideration. Moreover we offer attractive fringe benefits (e.g. profit sharing for all employees, modern company pension, childcare facility, training possibilities and global career opportunities). In accordance with the Austrian collective labour agreement, we advise you that the minimum gross annual salary for this role is 45.780,- euros.

Contact: Kathrin Rainer, HR Manager
Sandoz is an equal opportunity employer
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