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.
- 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 / email@example.com
Please note your CV will never be released without your expressed permission.