Regulatory Affairs Specialist

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)
• Compiles and submits clinical trial applications to ECs according to national requirements and follows-up when applicable
• 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. MS Word, Excel and PowerPoint
• Good organizational, record retention and time management skills
• Good working knowledge of all pertinent regulatory requirements (GCP, ICH, and national and local and regional regulations and requirements) as they relate to regulatory documentation required for clinical trial conduct Knowledge of the various types of regulatory documents required and required content

Education: Bachelor degree or above, major in pharmacy or medical science related fields.

• Experience: 1-2 years of experience in Drug regulatory affairs i.e. drug product license maintenance and PMF/DMF registration etc.

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.