Regulatory Affairs Manager- Clinical Trial Applications

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. As Regulatory Manager, you will work in Global Regulatory Affairs team, a successful and driven team that provides consultancy for all ICON projects globally as well as stand-alone contracts with clients. You will manage Regulatory Affairs activities on regulatory projects and clinical trials undertaken by ICON. You will be independent, able to effectively manage matrix teams and have regulatory project management experience. The role: • As a Manager, you will be expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. • Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken. • Prepare and /or support proposals and bids. • Effectively manage all the aspects of allocated projects in timely manner including tracking (time and resources), proactive identification of risks, scope change, financial implications and provision of solutions for approval by Directors. • Participate in regulatory and/or clinical trials project teams as required. • Outside of project teams efforts, you will seek to improve and optimize information/communications with in RA on emerging regulations • You will help RA group to develop strategies to build our capability to use emerging legislation to ICON’s competitive advantage. You will need: • Significant regulatory affairs experience including major experience in Pharmaceutical/CRO experience. • Demonstrable experience within regulatory affairs, including document preparation and/or writing, clinical trials, post-licensing activities and regulatory agency interaction • Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail. • Excellent written and communication skills • Good written and spoken English. • Proficient in the use of Microsoft Office. • Bachelor’s degree, or local equivalent, in the sciences, or equivalent experience qualification. Masters’ degree or higher in the sciences, preferred. Benefits of Working in ICON: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.