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Senior Regulatory Affairs Specialist – Tipperary South

Senior Regulatory Affairs Specialist (Tipperary)

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.

Duties:

  • 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

Requirements:

  • 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 / lee@optimizerecruitment.ie
Please note your CV will never be released without your expressed permission.

REF: LD-21567

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