Manager, Regulatory Strategy - US Regulatory (IND)

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. Manager, Regulatory Strategy: United Kingdom- Remote or Hybrid (Reading, Swansea) The Role: We are looking for passionate, resilient, and inspiring individuals to join our team. As the Manager, Regulatory Strategy, you will represent the Regulatory Affairs function on project teams and client meetings to provide regulatory guidance and strategy specifically focused on leading US FDA meetings and submissions support drug market transitions. Job Description Summary: Participate in provision of Regulatory expertise in strategic drug development across multiple areas. Take part in preparation of strategic development and submission plans. Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and Internally) Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities Contribute to at least two of the following areas: Interactions with Regulatory agencies, early phase consulting, Development Planning (PDP/RDP/CDP), Scientific/Agency advise, orphan drugs/pediatric development, medical devices, Reg Intelligence, due diligence, strategic CT support/GCP compliance, biologlcal/blotech/biosimilars, small company support (incl. SOPs development etc.) As Regulatory Expert, build effective teams and Involve junior members of the team into more complex regulatory issues. Mentor and train across function to support the wider Regulatory Department. Knowledge/Skills/Attributes Leading FDA pre -IND, End of Phase 2 and Pre NDA/BLA meetings with FDA. Experience with small molecules, biologics, gene therapy and cell therapies. Post market support experience Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding Planning and organization: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively. Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation Experience in client interaction and/or in a consulting environment is advantageous Experience in regulatory writing, meeting packages, dossiers What you need Minimum of a Bachelor's degree in Regulatory/Life Sciences Strong background and Regulatory experience in Pharma, Biotech, or related industry with emphasis on US Regulatory Affairs Knowledge of IND/NDA/BLA requirements Experience liaising with the FDA and conducting meetings to resolve any issues/concerns Comfortable being in an advisory based position to present, meet client requirements and a precise, professional and personable approach. Experience supporting client development activities and people management. Experience in Gene Therapy preferred Sound knowledge of the life cycle of a drug development program Why join us? Ongoing development is vital to us, and as the Sr Regulatory Affairs Manager, you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success. 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. #LI-HP2 #LI-Remote To be considered for this role you will be redirected to our careers page & prompted to create a jobseeker account here. To start the process, click the Continue to Application or Login/Register button below. Benefits: Work From Home