Regulatory Affairs Manager

4 weeks ago

Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time
Join Our Team as a Regulatory Affairs Manager

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 play a crucial role in developing regulatory strategies for innovative medicinal products and supporting Clinical Trial Applications under the new Clinical Trials Regulation.

About the Role

As a Regulatory Affairs Manager, you will be responsible for:

  • Developing regulatory strategies during development, approval, and post-approval phases for submissions to EU Competent Authorities.
  • Obtaining regulatory approvals and other feedback or decisions from European Competent Authorities.
  • Supporting Clinical Trial Applications under the new Clinical Trials Regulation.
  • Providing regulatory guidance to cross-functional teams within Teva.
Requirements

To be successful in this role, you will need:

  • 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.
  • Excellent written and verbal communication skills, with the ability to present and communicate effectively with local and global groups.
What We Offer

We offer a competitive package, including:

  • 25 days of annual leave.
  • A hybrid approach to home working.
  • 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.

We are an equal opportunities employer and welcome applications from all qualified candidates. If you are passionate about regulatory affairs and want to join a dynamic team, please submit your application.

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