Regulatory Affairs Associate
- Experience Level
- Experienced (non-manager)
PRA Health Sciences are an award winning CRO.
Commitment to our staff is only surpassed by our commitment to advancing treatment options available to patients. We understand the importance of supporting and investing in our people. With 20% of our employees promoted last year, we don’t need to tell you that your career will thrive at PRA. We know it. And we can prove it. As we grow, so will you. Come discover your PRA.
Due to ongoing Global expansion, our business is thriving. We are looking for enthusiastic Regulatory Affairs professionals to grow with our business.
The Regulatory Affairs Associate (RAA) is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met in the UK and Ireland. This includes communicating the status of submissions to the Global Regulatory Lead (RAL) and Start-Up Lead (SUL) and working with them to mitigate risks to Sponsor deliverables. Summary of tasks, including but not limited to:
- Preparing, submitting and following up on initial and amended Regulatory Agency (RA, Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval.
- Provide submission strategy to the Global Regulatory Lead along with all requirements and documentation requests to actualise the proposed strategy.
- Responsible for providing review of the translation into the local language of clinical trial supply labelling to ensure it meets local regulatory requirements. Additionally, ensure that Insurance Certificates, Country Specific Informed Consent Forms and other patient documentation adhere to country requirements
An ambitious regulatory professional with experience of working on regulatory submissions. Additional requirements include:
- An undergraduate degree ideally in science, or health-related field.
- Knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
- Fluency in written and spoken English.
- Prior experience in the preparation of UK and Ireland RA and Central IEC submissions for Clinical Trial Applications within the UK and Ireland
- Post-graduate interested in an entry level position in Regulatory
Your health, your family, your career, your money — the things that matter to you, matter to us. We consider part time or full time working.
The benefits of PRA just keep getting better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com