Regulatory Affairs Associate - UK & Ireland
- Experience Level
- Entry level
PRA Health Sciences are an award winning CRO.
We are proud to have won Pharma Times “Clinical Research Company of the Year” in 2017 for the fourth consecutive year. We aren’t winning these awards by chance; PRA is being recognised industry-wide for our dedication to the future of clinical development. Most importantly for you, at PRA we recognise that our success is down to our people.
PRA has been contributing to the battle against COVID since day 1 and whilst there is no doubt that we are currently working in unprecedented times, PRA has been great at creating a sense of unity amongst our employees and globally. Our Leadership have remained dedicated to ensuring that our employees supported and productive so if you join PRA you can expect increased technology and IT support for all global home-workers as well as access to extensive health & wellbeing resources.
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 as Regulatory Lead across multiple regions. 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 or
- 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
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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