ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center 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.
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.
Summary:
• A Regulatory professional who contributes to drug development, as part of the Regulatory Affairs team, through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications, marketing applications and post approval support
• Manager Regulatory Affairs is a Regulatory professional who will have prior experience with several areas of Regulatory affairs (e.g., CTA/IND/MAA) and the ability to lead internal teams and carry out regulatory activities and submissions independently
• May work as part of a regulatory or cross-functional team depending on the size and nature of project
• Contributes to ICON Regulatory Affairs through their understanding of Regulatory process and interpretation of guidelines to develop best practices
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 knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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.
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.
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