Regulatory Affairs Professional 3+ years Experience

This leading pharmaceutical group has operations in South Dublin and the UK and are focused on the development and commercialisation of speciality products and other high-value niche products. Due to growth – there is an opportunity for a Regulatory Affairs professional to join their Dublin operation with work from home arrangements.

The Role:

Reporting into the Associate Director for Regulatory Affairs you will work cross-functionally with Quality and Artworks and also liaise with the manufacturing site in the UK. There are new products under development which will add to the current impressive portfolio of products currently under commercialisation.

Main responsibilities:

  • The review of current registration dossier for all marketed products to identify and record dossier completeness, compliance with guidelines/legislation, ongoing regulatory issues and outstanding regulatory commitments
  • To ensure the timely preparation and compilation of the registration dossier for assigned projects in accordance with EU and international standards
  • To manage and coordinate various regulatory activities throughout the life-cycle of the project/product

The Person:

You must possess the following to be considered:

  • BSc or MSc in Science or related
  • 3+ years Regulatory Affairs experience within the Pharmaceutical sector
  • Eligible to live and work in the EU

The Benefits:

  • Competitive salary
  • Pension
  • Flexitime
  • Working from home options

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

Salary: €45000 - €50000 Location: Dublin South