Regulatory Affairs Manager – US Markets

Our client is a global speciality pharmaceutical company focused on improving the lives of patients while creating value. This company develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications through its operating companies. Employing upwards of 6,000 staff worldwide, they operate virtual Quality, Supply Chain, Regulatory Affairs and Technical Operations from their HQ in Dublin. These functions are responsible for their externally manufactured products and own branded manufacturing operations.

The Role:

Reporting to the Director for Regulatory Affairs you will manage Regulatory Affairs activities for a portfolio of products.

The Person:

The successful candidate will possess the following:

  • A third level degree in a science related field
  • 5+ years industry experience in Pharmaceutical Regulatory Affairs
  • Proven experience with European and US markets
  • Working knowledge of regional GMP requirements where they impact on Regulatory Affairs
  • Working knowledge of the differences between EU, Global and US Marketing Authorisation Regulations
  • Ability to leverage and optimise partnerships with other functions within EVL and company-wide
  • Eligible to live and work in EU.

To discover more about this opportunity, apply now or contact Gillian McMurrough at HRM on +353 1 6321827 for a confidential discussion

Salary: €0 - €71000 Location: Dublin South