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.
ICON is adding a Global Regulatory Affairs Lead to the Global Regulatory Clinical Services (GRCS) team to help ICON’s clients navigate the intricate regulatory agency and ethics committee approval and life cycle challenges. The GRCS group has been established for 30+ years and is made up of 550+ regulatory professionals based in over 46 countries.
LOCATION: Mexico (office-based with remote flexibility or home-based)
OVERVIEW OF THE ROLE:
The Global Regulatory Affairs Lead (GRAL) 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.
- Providing the Sponsor and internal Project Team information on regulations governing the clinical trial at a project level and answering any Sponsor questions
- Provide submission strategy to the client along with all requirements and documentation requests to actualize the proposed strategy
- Preparation of the Core Clinical Trial Application (CTA) 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 Defense Meetings
TO BE SUCCESSFUL YOU WILL NEED:
- Experience working as a Regulatory Lead across multiple regions including Latin America
- Experience with clinical regulatory affairs (GCP) is a must
- Experience in the preparation of Regulatory Agency (RA) and Central Independent Ethics Committee (IEC) submissions for Clinical Trial Applications
- Expert knowledge of current regional guidelines and regulations and the ability to understand new guidelines and regulations
- Strong communication skills
- Fluency in written and spoken English
- Bachelors degree (ideally in science or health-related field)
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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