(Senior) Manager (m/w/d) Regulatory Affairs
Ulm, Germany, 89079
Who are we?
We want to improve the life of our patients. That is our daily mission. We are proud of our 2,900 employees who provide millions of people with essential medicines every day. Health needs a healthy environment - we are committed to this and, as an environmental pioneer in the German pharmaceutical industry, we set our German sites carbon-neutral in 2021.
And that's not all: we are represented in over 60 countries worldwide, the market leader in generics and the home of Germany's well-known pharmaceutical brand ratiopharm. As a full-service provider, we offer a wide range of approximately 3,500 products. These includes innovative medicines, generics, biosimilars and over-the-counter medicines. In our global network, we are constantly developing new, innovative therapies to further improve healthcare for all people. Several teams located at the German site are part of Global and European departments and thus contribute to Teva’s success around the globe.
In a nutshell: We are Teva - and we are very proud of it!
If you feel like us and if you are someone who enjoys exploring unknown paths - then we would like to get to know you. Are you also enthusiastic about global markets and pioneering technologies? And would you like to develop the future of healthcare at a leading provider of medicines? Fantastic! Then become part of our team!
Curious about the German site? Fantastic, then take a look: https://www.youtube.com/embed/73i_f4kpfVU?rel=0&showinfo
A Day in Global Regulatory Affairs Innovative Medicines
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.
Who are we searching for
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
What we offer
At Teva
... we take care of your health (among other things through a company health management system, a company doctor, physiotherapy, sports activities and a company canteen)
... you have time for your family (through our own company kindergarten and holiday camps for schoolchildren, as well as 30 days of vacation)
... you can develop your potential to the fullest (through a comprehensive virtual training program)
... your achievements are valued accordingly (e.g. through recognition and Senior-Leaders-Programs, as wellas various company events)
... we think together with you about your future (e.g. through a company pension scheme)
Function
Reports To
VP Specialty Regulatory Affairs - EU and CMC
Contact
Orsolya Valkovics
Human Resources
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