Manager / Senior Manager of Global Regulatory Affairs
Location : United Kingdom
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
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.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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 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.
Additionally, as a Manager, you may also assume responsibility for a small number of direct reports, and be involved in departmental initiatives regionally or globally. What we can offer you: At ICON we see our company not just as your next role, but your career and here is what we can offer you, dependent on your experience:
- A clear and well structure development pathway with access to effective training and coaching
- Become part of the supportive and extremely knowledgeable regulatory professional team who are collaborative.
- Have a platform to share and provide ideas for process improvements and problem solving solutions where we value your input.
- If you are passionate about business growth, become part of expanding our business within bid-defence preparations and meetings