Senior Manager, Regulatory Affairs

h3Senior Manager
- Regulatory Affairs /h3 pICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. /p pAs a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. /p pAs a bSenior Manager, Regulatory Affairs /bat ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. /p h3What You Will Do: /h3 pYour focus will be on overseeing regulatory affairs delivery, coaching your team, and driving continuous improvement.

Key responsibilities
include: /p ul liParticipate in provision of regulatory expertise in strategic drug development across multiple areas. /li liTake part in preparation of strategic development and submission plans. /li liBe involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally). /li liBe a trusted partner
- represent the Regulatory Affairs Department in business development activities and generate new business opportunities. /li liContribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices /li /ul h3Your Profile: /h3 pYou will have a strong background in regulatory affairs, with proven management experience and a commitment to quality delivery. /p pRequired qualifications and

experience:
/p ul liBachelor's degree in a relevant scientific discipline or healthcare-related field /li liEU/APAC: In-depth proven regulatory affairs expertise. Minimum of 7 years' experience, supervisory experience, and pharmaceutical/CRO industry experience. /li liUS/LATAM/CAN: A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry. /li liDemonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction. /li liStrong organizational skills, ability to manage multiple tasks, and meticulous attention to detail. /li liExcellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize. /li /ul h3What ICON can offer you: /h3 pOur 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. /p pIn 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. /p pOur benefits examples include: /p ul liVarious annual leave entitlements /li liA range of health insurance offerings to suit you and your family’s needs. /li liCompetitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. /li liGlobal 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. /li liLife assurance /li liFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. /li /ul pVisit our careers site to read more about the benefits ICON offers. /p pAt 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. /p pAll 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. /p pIf, 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 /p