Senior Regulatory Affairs Officer

Global innovator organisation with core competencies in the fields of pharma, biotech, medical devices and diagnostics to name but a few. Employing upwards of 30,000 people worldwide, this organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life.

The Position

As Senior Regulatory Affairs Officer to be based within the Quality Department – you will be responsible for the following:

  • To Obtain and maintain Marketing Authorisations (MA’s) and Clinical Trial Authorisations (CTA’s) for a designated list of products.
  • To maintain an awareness of current Irish & EU regulatory requirements.
  • Deputise in the absence of the Head of Regulatory Affairs.
  • To submit applications (new MA’s/Clinical Trials/Variations/Renewals etc.) for National/EU MA ‘s and negotiate with the HPRA to resolve any issues to minimise the delay in approval.

Requirements

In order to be considered for this role you must possess the following:

  • A Third level degree qualification in Life Science or similar
  • 2-4 years regulatory affairs / compliance experience working within the Pharmaceutical or Biotechnology industry sectors.
  • Knowledge and exposure to the HPRA and knowledge of the Irish Market.
  • Excellent team working and communication skills.
  • Strong negotiation, influencing, presentation skills.
  • Strong visionary, strategic, tactical and motivational skills.
  • Eligible to work within EU?

Benefits:

  • Competitive salary – may vary based on experience
  • Healthcare
  • Life insurance
  • Pension scheme

To learn more, apply online or contact Gillian McMurrough +353 1 6321827 for a confidential chat.

Salary: €45000 - €65000 Location: Dublin West