Regulatory Affairs Manager

4 weeks ago

Harlow, Essex, United Kingdom Tevapharm Full time
Join Our Team as a Manager/Senior Manager - Regulatory Affairs

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

About the Role

As a Manager or Senior Manager - Regulatory Affairs, you will be responsible for developing regulatory strategies during development, approval, and post-approval phases for submissions to EU Competent Authorities. You will also obtain regulatory approvals and other feedback or decisions from European Competent Authorities during the development of innovative medicinal products.

You will support Clinical Trial Applications under the new Clinical Trials Regulation and provide regulatory guidance to cross-functional teams within Teva.

Key Responsibilities
  • Develop regulatory strategies for submissions to EU Competent Authorities
  • Obtain regulatory approvals and feedback from European Competent Authorities
  • Support Clinical Trial Applications under the new Clinical Trials Regulation
  • Provide regulatory guidance to cross-functional teams
Requirements
  • Strong scientific background with a BSc degree in Life or Pharmaceutical/Healthcare Sciences
  • 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
  • Strong leadership and interpersonal skills
What We Offer
  • 25 days of annual leave
  • Hybrid approach to home working
  • Pension scheme
  • Car or car allowance
  • Life & Critical Illness Insurance
  • Private health insurance for you and your family
  • Sports and Health Programme
  • Recognition programs to reward our employees
Why Teva?

Teva Pharmaceuticals is committed to equal opportunity in employment. We are a global leader in the pharmaceutical industry, with a mission to make good health more affordable and accessible.

We offer a dynamic and inclusive work environment, with opportunities for professional growth and development.

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