[Remote] Regulatory Project Manager

Note: The job is a remote job and is open to candidates in USA. ICON Strategic Solutions is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of new medicines and treatments. The Regulatory Project Manager will collaborate with cross-functional teams to plan and deliver compliant regulatory submissions, while managing project plans and operational aspects related to submissions.ResponsibilitiesRepresents the regulatory project and submission management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans in line with the client’s needs and regulatory team goalsPartners with document providers to project manage the timely receipt of submission ready documents for inclusion in global dossiersCommunicates external agency submission standards and internal business submission processes to ensure compliance and efficiency in the delivery of submissionEnsures that company is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to global regulatory project and submission managementSkillsA relevant educational background in a life-sciences disciplineSome previous experience in submissions, regulatory operations or publishingStrong project management skillsFluency in EnglishNeed experience in: Microsoft ProjectExperience supporting BLA's/IND'sBenefitsCompetitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysCompany OverviewICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. It was founded in undefined, and is headquartered in Dublin , GB, with a workforce of 10001+ employees. Its website is https://www.iconplc.com/services/strategic-solutions/.