Regulatory Affairs Manager
Rotkreuz, Switzerland
vor 5 Tg.

Job Description

Takes care of all drug regulatory affairs matters regarding the assigned indication group at Sandoz. A division of Novartis, Sandoz is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.

Acts as an interface between global Regulatory Affairs departments and Swissmedic in order to obtain new marketing authorizations, support new product launches and ensure regulatory compliance.

Your responsibilities include, but not limited to :

  • Preparation of the regulatory strategy for new submissions.
  • Timely submission of new products to Swissmedic in agreement with the yearly target.
  • Obtain a number of marketing authorizations in accordance with the yearly target. Drive product maintenance to ensure regulatory compliance.
  • Provide close regulatory support to the product launch work stream. Strategic business partner to Business Development, Quality Assurance, Supply Chain as well as for other Global Regulatory Groups (RCCs)
  • Follow trends in the regulatory environment and legislation and assure awareness and alignment within the department, in order to meet future requirements on time always work in accordance with Good Regulatory Practice
  • Minimum requirements

    What you’ll bring to the role :

  • Pharmacist or natural scientist preferably with medical background
  • 2-3 years Regulatory experience
  • German (fluent), English (advanced) French (desirable) and Italian (an asset)
  • Why consider Sandoz?

    927 million. That’s how many lives our Novartis group products touched in 2017. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?

    We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

    We are Sandoz, a Novartis Division. Join us and help reimagine medicine.

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