.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.**Including but not limited to**:- Prepare, compiles, coordinates, and review regulatory submissions for the conduct of clinical trials (IND / CTA) and for product registration (NDA / MAAs, CTDs / eCTDs)- Develop and maintain rapport with regulatory agencies to facilitate submissions process and efficiently manage and resolve agency inquiries and/or issues- Interface with regulatory authorities on strategic regulatory and technical matters, as appropriate- Review regulatory documents for consistency and quality- Secure import/export license for study medication and management of the import/export process- Works closely with Clinical Project Team from the start of a trial to its completion to ensure study and regulatory compliance when applicable- Development and maintenance of tracking tool for sponsor reporting- Development and following of clinical trial agreement with the sites when applicable- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the region and discipline areas relevant to assigned projects- Participate in regulatory affairs meetings and training initiatives, project team meetings, and maintain relationships with other departments, and sponsors- When applicable will review the essential documents required to authorize investigational product shipment- Attend functional meetings with Sponsor and team management- Where applicable, responsible for oversight of Regulatory File Room- Support in the creation of regulatory templates- Assist in the development and revision of local regulatory processes and SOPs- Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.**Knowledge, Skills, and Abilities**:- Excellent verbal and written communication skills- Appropriate English language skills Strong computer literacy e.G