Manager/Senior Manager - Regulatory Affairs - Innovative Medicines, Europe

Together, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Its a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the worlds leading manufacturer of innovativegeneric medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but were always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

We are recruiting for aManager or Senior Manager - Regulatory Affairsto work within the Global Regulatory Affairs Innovative Medicines (Europe) team. You will be working with keyInnovative productspart of Teva´s Pivot to Growth strategy.

Do you know that our Harlow office is the Centre of Excellence (CoE) for Regulatory Affairs within Teva, with teams covering both European and global licensing for medicines and over-the-counter (OTC) products? The site is conveniently located half an hour commute from central London.We have a hybrid approach to home working!

A day in the life of a Manager/Senior Manager Regulatory Affairs...

• 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.
  

Your experience and qualifications

Do you have?

• 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 experiencein Immunology and/or Oncology and/or Gastroenterology and/or Respiratorytherapeutic 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
  

Are you?

• 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

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