Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting aGlobal Regulatory Affairs AssociateThe resource will join the Global Regulatory Affairs department – Rest of the World (RoW), with a direct report to the Regulatory Affairs Manager to operate in the above mentioned team.
The resource will be responsible for handling a specific portfolio of products, guaranteeing the obtainment of new registrations and/or the maintenance of the existing ones in the Region in scope.MAIN ACTIVITIES AND RESPONSIBILITIESWithin the RoW Regulatory Affairs team, the resource will deal with the registrations and/or life cycle maintenance activities of the products in the area.
It will include, at least:Planning/organizing activities for preparing new product registration and maintenance of the existing registration through variation procedures and renewalsWorking in cooperation with technical internal functions (such as Quality Assurance, Medical-marketing, Clinical Sciences, Pharmacovigilance), and local regulatory teams or external partners for the preparation of the regulatory application related to new registrations and lifecycle managementPreparation of the master data package to be shared with the local regulatory affairs contacts in order to proceed with the customization, as necessary, and submission of the application to the competent Authority/iesApplication of the existing working flows and Company proceduresMonitoring and understanding of new RA regulations and guidelines for the area of responsibilityJOB REQUIREMENTSBachelor Degree in scientific environment, including, but not limited to, Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry, is mandatory;1 year of previous experience in the regulatory environment is preferred;Fluent in English, both written and oral;The candidates should be dynamic, proactive and willing-to-do person;The candidate should have excellent interpersonal, organizational and communication skills, capability in working in a team and good problem-solving attitudeContract type: fixed term with prospects #J-18808-Ljbffr