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Regulatory Affairs Manager

2 months ago


Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time

Unlock Your Potential in Regulatory Affairs

We are seeking a highly skilled Regulatory Affairs Manager to join our Global Regulatory Affairs – Innovative Medicines (Europe) team at Teva Pharmaceuticals. As a key member of our team, you will be responsible for developing regulatory strategies during development, approval, and post-approval phases for submissions to EU Competent Authorities.

About the Role

  • 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.

Requirements

  • 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 a significant advantage.
  • Strong leadership and interpersonal skills.

What We Offer

  • An excellent opportunity to work with a leading pharmaceutical company.
  • A competitive salary and benefits package.
  • A hybrid approach to home working.
  • 25 days of annual leave.
  • A pension scheme.
  • Life & Critical Illness Insurance.
  • Private health insurance for you and your family.
  • Sports and Health Programme – including health days and nutritional counselling.
  • On-site Canteen.

Join Our Team

At Teva Pharmaceuticals, we are committed to providing a supportive and inclusive work environment. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application.