Manager of Global Regulatory Affairs Sweden, Portugal, Spain, Denmark, Belgium, Netherlands, France, Italy, Germany,
At PRA, we don’t make our 15000+ people great; it’s the other way around. As we have grown to a top-5 CRO, we have maintained the feel of a small company, dedicated to collaboration and passion for what we do.
We always have a desire to keep seeking new and better ways to operate. We don’t settle for the same old ways. Our passion for improving patient lives worldwide permeates all that we do. Put simply, we care.
You are: Friendly, proactive and collaborative. Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have: An ambitious regulatory professional with experience of working as a global 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, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
- Read, write and speak English; fluency in host country language required.
- A team-first approach which fosters positive working relationships with your study team colleagues
- Fluency in written and spoken English.
Position Overview: Due to ongoing Global expansion, our business is thriving. We are looking for enthusiastic Regulatory Affairs professionals to grow with our business. The Manager of Global Regulatory Affairs is responsible for coordinating all Central Ethics Committee (CEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. A highly visible role, you will interact daily with other study team members including the clinical team, project management and other functional areas. This includes communicating the status of submissions to the Start-Up Lead(s) (SULs) and working with them to mitigate risks to Sponsor deliverables. As a Manager of Global Regulatory Affairs, no two days are the same. Whether it’s meeting with the start-up team, reviewing proposal documents or discussing global submission strategy with a client, you can expect plenty of variety in this fast-paced and active role. Summary of tasks, including but not limited to:
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and Bid Defence Meetings (BDMs).
- Provide the Sponsor and internal Project Team information on regulations governing the clinical trial at a project level and answer any Sponsor questions surrounding these topics.
- Provide submission strategy to the client along with all requirements and documentation requests to actualise the proposed strategy.
- Prepare the Core Clinical Trial Application and perform QC on the content of all central submission packages.
- Preparation of the core Informed Consent Form and co-ordination of the sponsor review of local adaptations.
- Coordinate a team of Local Regulatory Affairs Leads to ensure contractual timelines are met
- Keep abreast of current data, including Regulatory knowledge, trends, advances in area of expertise, and developments as they relate to the projects and the department.
- Contribute to departmental process improvement work streams.
Find a Job Find Candidates