Director, Regulatory Affairs

Director, Regulatory Affairs ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Director, Regulatory Affairs Due to a number of exciting new projects being awarded to ICON, we are seeking to expand our team and expertise, with the recruitment of a Director of Regulatory Affairs within our US team. We are looking for passionate, resilient, and inspiring individuals to join our Strategic Regulatory Affairs (SRS ) team. SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services As a Director, Regulatory Affairs, you will create a culture of, process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs. Representing ICON as a Subject Matter Expert for Regulatory Affairs in the US market you will proactively communicate objectives and results with clients offering strategic regulatory advice. In this role, you will be responsible for regulatory strategy for a combination of current and prospective clients in the US for drugs and biologics. As a senior member of the SRS team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met. You will also maintain client relationships in the support of future business as the position participates in business development activities.

Responsibilities and accountabilities:

Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients. Act as scientific thought leader for ICON. Support initiatives to ensure ICON is at the leading edge of new regulatory developments e.g.

DCT, COVID-19, GMO, ATMP

development, Cell and Gene therapy etc. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise, consulting with other resources within the organization as required. Manage workflow including prioritizing project objectives, and establishing timeframes for projects with clients and managing client contracts. Effectively prioritize and complete multiple projects within established timeframes and within budget Train, coach, and develop assigned individuals to build overall team expertise Develop and implement strategies and regulatory submissions for PIP, OD, SME, MAA and post-licensing activities as applicable. Function as primary liaison with FDA for designated projects and designated clients Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including Independent development of project plans and scientific content for clients. Achieve a good conversion rate of submitted to won proposals. Act as scientific thought partner with the client and the project team throughout the project. May lead a team 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

Education/ Experience:

Bachelor's degree in a relevant discipline, preferably in life sciences, or other healthcare field. Advanced degree (MSc., PhD., M.D., Pharm.

D, MBA) in the biological, medical, chemical or engineering field may be beneficial. Minimum of 12-15 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on US Regulatory Affairs Experience supporting client development activities and people management.

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply