Regulatory Affairs Coordinator Central and Latin America

4 giorni fa

monza, Italia Jobbit A tempo pieno

Regulatory Affairs Coordinator Central and Latin AmericaRegulatory Affairs Coordinator Central and Latin America role for a pharmaceutical client in Florence, Italy. The Global Regulatory Affairs Department seeks a dedicated, detail-oriented regulatory professional to ensure compliance across diverse markets and support timely submissions.ResponsibilitiesProvide support to the RA associate in planning/organizing activities for preparing new registration plans and maintenance of existing registrations through variations and renewals.Collaborate with technical functions and regional/regulatory teams to define the best strategy to register and maintain the Group product portfolio.Work with technical functions and local regulatory teams to plan activities for new registrations and for maintaining existing registrations through variation procedures and renewals.Oversee existing licenses toward finalization of the master data package for transfer to the regional office for submission; cooperate with internal functions and local teams for lifecycle activities.Provide compliance checks on license content and ensure proper application of processes and company procedures.Interface with other company departments (R&D, Marketing, Manufacturing, PV) to address regulatory authority requests.Provide regulatory intelligence related to new regulations and guidelines to be shared with Corporate teams.Coordinate the development and implementation of internal Standard Operating Procedures.Maintain staff by recruiting, selecting, orienting, and training employees; support a safe, secure, and compliant work environment.Contribute to team effort by accomplishing related results as needed.Support financial objectives by assisting with forecasting, budgeting, scheduling expenditures, and analyzing variances.Job RequirementsMaster degree or higher in scientific fields is mandatory.At least 5 years of experience coordinating international Regulatory Affairs teams or in an equivalent role, including experience in the Central and South American region.Proven track record of successful regulatory applications in the region.Fluent spoken and written English; knowledge of Spanish is a plus.Dynamic, proactive, and willing-to-do person.Excellent interpersonal, organizational and communication skills; ability to work in a team and good problem solving and leadership attitude.Experience in people coordination is preferred.Other DetailsTempo pienoSettore: AltroRuolo: AltroSeniority levelMid-Senior levelEmployment typeFull-timeJob functionLegalIndustriesManufacturingGet notified about new Regulatory Affairs Coordinator jobs in Florence, Tuscany, Italy.#J-18808-Ljbffr

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