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.

 

Apply Now






PDF, Word Documents only accepted

Leinster Appointments is committed to providing a professional service where all CVs are kept confidential and will not be submitted to any third parties without candidate’s knowledge or consent.
By applying, you are giving consent for Leinster Appointments to contact you about this job or similar positions.

I have read and agree with the Leinster Appointments Privacy PolicyI agree