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Senior Regulatory Affairs Specialist (Contract) – Tipperary South

Senior Regulatory Affairs Specialist (Tipperary)
Maternity Contract (9 months)

Optimize are currently recruiting on behalf of a well established pharmaceutical client in County Tipperary for an experienced Regulatory Affairs professional to join their expanding RA team.

Successful candidates will report to the Director of Reg Affairs & be based at the company’s manufacturing facility.

Salary for the role is €45K DOE.


  • 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
  • Comply with SOP’s and assist in their development and review
  • Determine and communicate submission and approval requirements
  • Respond to questions raised by regulatory authorities in a timely manner
  • Negotiate with regulatory authorities to achieve most favorable conditions for marketing authorisations or variations
  • Commission and approve artwork for compliance prior to final signoff
  • Monitor legislation and communicate updated regulatory requirements with the relevant stakeholders/business units
  • Review GMP documentation for regulatory compliance


  • Educated to degree level in a life science with significant experience in RA
  • Ability to work on own initiative
  • Understanding of the pharmaceutical industry and its day to day operations
  • Ability to interact with authorities in an appropriate manner
  • Exceptional eye for detail

For more information and to discuss similar opportunities, please contact Lee in the strictest of confidence on 0858072559. Please note your CV will never be released without your expressed permission.

REF: LD-21568

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