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Contact Info
Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Senior Regulatory Affairs Executive


Reference:SMC5769 Location: Tipperary
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • Comply with SOPs and assist in their development and review;
  • Operate and propose improvements to internal systems;
  • Assist in the development of regulatory strategies;
  • Determine and communicate submission and approval requirements;
  • Assess the acceptability of documentation for submission;
  • Coordinate and prepare submission packages for regulatory agencies.Monitor the content of the dossiers ensuring the content is consistent, understandable and the results clearly expressed and that open questions have been dealt with;
  • Respond to questions raised by regulatory authorities by obtaining the relevant information from departments concerned;
  • Negotiate with regulatory authorities to achieve most favourable conditions for marketing authorisations or variations;
  • Commission and approve artwork for compliance prior to final signoff;
  • Draft Summary of Product Characteristics, Patient Information Leaflets and packaging;
Education & Experience
  • Educated to at least degree level in a life science with significant experience in regulatory affairs;
  • Membership of The Organization for Professionals in Regulatory Affairs (TOPRA) is preferable;

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.