Teva Senior Manager m/w/d Regulatory Affairs 

Germany, Baden-Württemberg, Ulm 

191457796

In this position you will develop regulatory strategies for Innovative Medicines during development and life-cyclemanagement for submissions to EU Competent Authorities. It means that you will contribute to discussions with Rapporteurs, CHMP members, EMA officials and representatives of European Competent Authorities to secure timely approvals with advantageous labelling during a product’s entire life-cycle.
As part of the Global Regulatory Teams based in Europe, you will contribute to global Clinical Developmentplans for adult and paediatric patients, provide regulatory guidance for registrations in Europe and participatein both strategic and operational EU specific regulatory aspects. You will ensure compliance and proactivelyidentify regulatory risks and ensure that remedial action is in place to address any perceived gaps insupporting data requirements.
Last but not least, you will support knowledge sharing to global cross-functional teams within Teva.

You are
... a great problem solver with substantial European regulatory affairs experience preferably gained in a European based company
... experience in pre-MAA activities (ODD, Scientific Advice) in particular clinical development activities, inmanaging development work, new submissions and maintenance work. Innovative Medicine experience in theImmunology therapeutic area is (for example Oncology, Dermatology, Respiratory) is also a significant advantage
... able to interpret regulatory requirements for medicines in Europe together with an awareness of thecommercial implications of pharmaceutical regulation

You have
... strong scientific background with at least a BSc degree in life or pharmaceutical/healthcare sciences, ideally with an MSc or PhD
... an ability to organise and direct diverse activities in a multi-disciplinary environment, communicating with global and local groups
... scientific and technical expertise, including the ability to develop robust regulatory plans covering all phasesof drug development
... leadership and inter-personal skills demonstrated in cross-functional and global collaborations

VP Specialty Regulatory Affairs - EU and CMC

Orsolya Valkovics
Human Resources

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