Global Regulatory Affairs Associate
- Experience Level
- Experienced (non-manager)
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. In December 2020 PRA was awarded ‘Best Company Culture’, ‘Best Company for Women’ and ‘Best Company for Diversity’. 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.
Due to ongoing Global expansion, our business is thriving. We are looking for enthusiastic Regulatory Affairs professionals to grow with our business.
The Global Regulatory Affairs Associate (GRAA) is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. This includes communicating the status of submissions to the Start-Up Lead (SUL) and working with them to mitigate risks to Sponsor deliverables. Summary of tasks, including but not limited to:
- Providing the Sponsor and internal Project Team information on regulations governing the clinical trial at a project level and answering any Sponsor questions surrounding these topics.
- Provide submission strategy to the client along with all requirements and documentation requests to actualise the proposed strategy.
- Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission packages.
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and Bid Defence Meetings.
Who you are:
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.
- Prior experience in the preparation of RA and Central IEC submissions for Clinical Trial Applications ideally across regions.
- Expert 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.
Your health, your family, your career, your money — the things that matter to you, matter to us.
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.