Job Reference 15272
Job type Permanent
Location West Dublin
Salary € 0-40,000, 40,000-60,000

The Role

Main responsibilities:

 

  • Ensure timely preparation and compilation of registration dossier in accordance with EU or relevant Health Authority standards and corporate requirements;
  • Communicate Health Authority approvals/final decisions to the relevant departments;
  • Respond to Health Authorities’ queries and deficiencies in a timely manner;
  • Manage international regulatory submissions according to company strategy and ensure registration deadlines are met;
  • Assess the impact on existing files when new regulatory requirements are issued;
  • Liaise with other departments to support the timely introduction of new products into markets;
  • Build departmental awareness of local regulatory requirements in global markets;
  • Archive the registration documentation according to internal standards; introduce and regularly update the internal RA database;

The Person

Main requirements:

 

  • Life sciences (BSc Chemistry / Biology, etc) or pharmacy degree
  • Minimum 4 year experience in a regulatory affairs environment in a pharmaceutical industry
  • Knowledge of IT tools specific for in RA and pharmaceutical sector

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