Regulatory Affairs Advisor

My client is a global innovator organisation with core competencies in the fields of pharma, biotech, medical devices and diagnostics. Employing upwards of 60,000 people worldwide with sales in the region of 20B globally, 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

Reporting to the Head of Regulatory Affairs the main objectives for this role are:

  • To manage assigned projects to ensure that a Regulatory Service is provided that meets the requirements of my client and RA management.
  • To co-ordinate and undertake the preparation of high quality licence applications in order to gain approval for marketing of products.
  • To ensure that the applications meet national and EC requirements.

The Person

The successful candidate will possess the following:

  • A Degree (BSc/MSc/PhD) in pharmacy, pharmacology or the biological sciences.
  • Experience in Irish/European drug registration activities.
  • Knowledge of EU and national regulatory requirements.
  • Ability to prepare high quality regulatory submissions.
  • Commercial awareness.
  • Good communication skills including the ability to influence by persuasion and, where appropriate, negotiation.
  • People management skills are important for this role both in terms of managing relationships within the Regulatory Affairs Department, and participating in cross-functional teams at both a local and regional level.

Benefits

  • Pension
  • Healthcare
  • Dental Insurance
  • Performance Bonus
  • Life Assurance

To Learn more apply online or call Gillian McMurrough directly on +353 1 6321827 or TEXT 0871213548

Salary: On Application Location: Dublin South