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Regulatory Affairs Associate

Location: Cork, Republic of Ireland Salary:
Sector: Regulatory Affairs Type: Permanent

The Role:

Are you a Regulatory Affairs Associate interested in joining an international pharmaceutical group dedicated to the research, development, manufacturing and marketing of pharmaceuticals? As a valued member of the RA team, based in Cork, you will be responsible for lifecycle management of Marketing Authorizations, and will act as the point of contact for correspondence with the HPRA and MHRA.

Day to Day:

As Regulatory Affairs Associate, you will:

  • Perform lifecycle management of Marketing Authorizations.
  • Act as contact person for relations and correspondence with the HPRA and MHRA
  • Assist in submission to HPRA and MHRA of Marketing Authorization Applications, Variations and renewals.
  • Monitor the national law on medicines and related documents and guidelines and alert to the HQs when changes in regulation can have an impact
  • Update of Regulatory Status for registered products.

Skills/Requirements:

Must haves:

  • BSc in biological sciences or a related discipline.
  • 3+ years' experience in a similar role with a major focus on Regulatory Affairs.

Desirables:

  • Experience working in a GxP regulated environment (e.g. GDP/GMP/GVP)

Company Culture:

As Medical Information and Regulatory Affairs Associate, you will be a part of a mid-sized team based in Cork. It is a busy environment with huge learning prospects, where training is a continuous process. If you would thrive in a family like environment in a growing company with great opportunity then this could be the role for you.

For immediate consideration, please apply below with an up to date CV. Not sure yet? No CV ready? Give me a call for more information.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales