Job Reference 14453
Job type Contract, Permanent
Location West Dublin
Salary € 0-40,000

The Role

Main responsibilities: 

  • Ensure timely preparation and compilation of registration dossier components in accordance to EU or relevant Health Authority standards, and corporate requirements
  • Under supervision of the senior RA person (if required), manage international regulatory submissions according to company strategy and ensure registration deadlines are met
  • Responding to Health Authorities' queries and deficiencies in a timely manner
  • Liaise with other departments to support the timely introduction of new product into markets
  • Maintain assigned products' Marketing Authorisations via submission of the appropriate variations and renewals in a timely manner
  • Communication of Health Authority approvals/final decisions to the relevant departments
  • Build departmental awareness of local regulatory requirements in relevant markets


The Person

Main requirements:

  • Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
  • Experience in a regulatory affairs environment required
  • Experience in the pharmaceutical industry an advantage
  • Working knowledge of current registration requirements for dossier preparation and procedure running an advantage
  • Solid knowledge of specific national requirements in usual target registration countries an advantage
  • IT tools utilised in RA department e.g. for Regulatory intelligence, eCTD, change control etc.


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