Regulatory Manager (Global Regulatory Affairs)

Overview

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.

Responsibilities

• Management of regulatory activities associated with  development programs. Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals. Provide guidance to multidisciplinary teams on the content, format, style and architecture of CTAs for ex-US/ex-EU studies.  Provide regulatory submission requirements ex-US/ex-EU.
• Accountable for ensuring the completeness and accuracy of regulatory submissions.  Participate in the planning, preparation and submission of regulatory documentation. 
• Responsible for coordination of global core documents
• Program level HA Query support including query tracking and response coordination.

Qualifications

You are:

Collaborative, innovative and a confident Regulatory professional.

• Previous experience working within Regulatory Strategy in either a pharmaceutical company, CRO or consultancy environment
• Bachelors degree ore equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above
• Atleast 5-10 years of relevant experience 
• Previouls leadership experience with INDs.
• Oncology experience highly preferred
• The ability to deliver a client-focused service and collaborate with other team members globally
• Fluency in English
• A degree-level qualification in a relevant life sciences discipline

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.