Senior Regulatory Affairs Lead

1 month ago


Harlow, Essex, United Kingdom Lifelancer Full time
About the Role

We are recruiting for a Senior Regulatory Affairs Lead to work within our Global Regulatory Affairs Innovative Medicines (Europe) team. As part of Teva ́s Pivot to Growth strategy, you will be working with key Innovative products.

Job Description

A day in the life of a Senior Regulatory Affairs Lead...

  • 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.
  • You will obtain regulatory approvals and other feedback 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 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

We are looking for someone with:

  • 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.
  • Experience in Clinical Trial Applications in the EU.
  • Innovative Medicine experience in Immunology and/or Oncology and/or Gastroenterology and/or Respiratory therapeutic areas is an advantage.
  • Strong leadership and interpersonal skills.
What We Offer

We offer a competitive salary, estimated at £80,000 - £110,000 per annum, depending on experience, plus benefits including hybrid working options, flexible holidays, and career development opportunities.

Apply Now

Please use the following link to apply: https://lifelancer.com/jobs/view/1dcbb660f3e5e8f6485c3ded47b9e84b



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