Regulatory Affairs Manager

4 weeks ago

Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time

The Opportunity

We are seeking a highly skilled Regulatory Affairs Manager to join our Global Regulatory Affairs – Innovative Medicines (Europe) team. 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.

Your Key Responsibilities

  • Develop and implement regulatory strategies for innovative medicinal products in the EU and globally.
  • Obtain regulatory approvals and feedback from European Competent Authorities during development and post-approval phases.
  • Support Clinical Trial Applications under the new Clinical Trials Regulation.
  • Obtain registrations for innovative medicinal products in the EU and maintain existing marketed product registrations.
  • Provide regulatory guidance to cross-functional teams within Teva.

Your Qualifications

  • 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.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

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