Manager - Regulatory Affairs - Innovative Medicines, Europe

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Teva

You will develop regulatory strategies during development, approval and post approval phases for submissions to EU Competent Authorities. Depending on your experience you may also have the opportunity to do this on a Global scale in the capacity of Global Regulatory Lead
You will obtain regulatory approvals and other feed-back or decisions from European Competent Authorities during development of innovative medicinal products
You will support Clinical Trial Applications under the new Clinical Trials Regulation
You will obtain registrations for innovative medicinal products, in the EU and to ensure that the registrations for existing marketed products are maintained
You will provide regulatory guidance to cross-functional teams within Teva

A strong Scientific background with a BSc degree in Life or Pharmaceutical/Healthcare Sciences – ideally with a MSc or PhD
Substantial European regulatory affairs experience (must have)
Experience in Clinical Trial Applications in the EU (must have)
Innovative Medicine experience in Immunology and/or Oncology and/or Gastroenterology and/or Respiratory therapeutic areas is a significant advantage, but we are open to consider any therapeutic area
Experience with Medical Devices and the Medical Device Regulation would also be an advantage
Strong leadership and interpersonal skills

An excellent written and verbal communicator and confident presenting/communicating with local and global groups
Able to work under pressure to meet tight deadlines
A strategic thinker with strong problem solving skills

Don't forget to mention EuroPharmaJobs when applying.

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