Regulatory Affairs Manager Lead

3 days ago


Harlow, Essex, United Kingdom Lifelancer Full time
Job Overview

We are seeking an experienced Regulatory Affairs Manager Lead to join our Global Regulatory Affairs – Innovative Medicines (Europe) team.

About the Role

This is a key opportunity for a professional with a strong scientific background and European regulatory affairs experience to develop regulatory strategies during development, approval, and post-approval phases for submissions to EU Competent Authorities.

Responsibilities
  • Developing regulatory strategies for innovative medicinal products in Europe and potentially globally as a Global Regulatory Lead.
  • Obtaining regulatory approvals and feedback from European Competent Authorities.
  • Supporting Clinical Trial Applications under the new Clinical Trials Regulation.
  • Securing registrations for innovative medicinal products in the EU and maintaining existing product registrations.
  • Providing regulatory guidance to cross-functional teams within Teva.
Requirements
  • 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, Oncology, Gastroenterology, Respiratory therapeutic areas, or other relevant fields.
  • Experience with Medical Devices and the Medical Device Regulation is advantageous.
  • Strong leadership and interpersonal skills.
Benefits
  • An attractive salary of approximately £65,000 per annum, depending on experience.
  • 25 days of annual leave and a hybrid approach to home working.
  • Pension scheme and private health insurance for you and your family.
  • Life & Critical Illness Insurance and Sports and Health Programme.
  • Recognition programs to reward employees with our company bonus scheme.
  • Virtual Learning Centre opportunities.

Teva Pharmaceuticals is committed to equal opportunity in employment. We value diversity and inclusivity in our workplace and encourage applications from candidates who share these values.



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