They are actively seeking to recruit a Regulatory Affairs Specialist to work at their offices in western Ireland. The Role: The Regulatory Specialist would be...
To work with the Clinical Trial Team Lead to ensure that appropriate content for specific submissions supporting R&D projects is developed and delivered to agreed timeframes and in compliance with internal processes and policies as they apply to the role.
- Coordination of CTA Substantial Amendment submissions to ensure timely delivery and ensuring the content is appropriate to each individual regulatory agency while maintaining compliance with company policy and procedures.
- Accountable to the Clinical Trial Team Lead for overall work plans.
- Accountability for agreed tasks and projects.
- Ensure independent communication, with a range of internal staff, in support achievement of the assigned goals.
- Ensure compliance with company CTA and maintenance process through timely action and completion of records in internal systems.
- Ensure quality of own work to agreed timeframes, including compliance with internal systems and record keeping.
Biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment.
This role requires a good understanding of submission requirements for multiple countries/submission types and an ability to work in a matrix environment.
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.