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We provide pharmaceutical and life science companies with the strategic, in-market, and executional expertise needed to deliver successful Regulatory Affairs and Market Access outcomes throughout the entire product life cycle and across international markets.We are looking for a REGULATORY AFFAIRS to join our INTERNATIONAL TEAM.You will play a key part in managing regulatory requirements to support product development, registration, and lifecycle management across multiple markets. Your knowledge will ensure compliance with local and international regulations, helping to successfully launch and maintain innovative products globally.Key Responsibilities:Prepares the regulatory documentations for development programs (IMPDs/INDs, IB, CTA forms, Scientific Advice/Protocol Assistance Briefing Document, Orphan Drug Designation submission package).Prepares the regulatory documentations for marketing authorization application (CTD Modules).Performs the gap analysis of technical documents versus module 3 and the evaluation of regulatory variations to update the regulatory dossiers – update of Module 3.Performs elemental Impurities Risk assessments and environmental risk Assessments. Ensures consistency, completeness, accuracy and adherence to regulations and applicable guidelines and to the client’s need for all regulatory submissions. Provides assistance during the procedures for the preparation of response documents.Identifies and communicates potential risks in submissions and anticipate regulatory responses through scenario planning.Builds and maintains professional contacts with scientific experts as well as with national and international authorities.Ensures that project work proceeds according to agreed deadlines through continuous contacts with all the involved parties (CMO, Sponsor...).Gives assistance during the procedure for preparation of the response document.Plans and manages regulatory procedures in the EU and outside the EU (e.g. new marketing authorization applications, variations, renewals, etc.) in coordination with the Client’s team and the contact with Regulatory Authorities together with or on behalf of the client.Gives support to the Client in the critical evaluation of the appropriate regulatory strategy.Essential requirements:Master's degree in Pharmaceutical Chemistry and Technology, Pharmacy or similar.At least 3 years of experience.Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.Soft Skills:Communication and teamwork.Attention to detail and organizational skills.Time management and problem-solving.Adaptability and resilience.Workplace:Pisa (hybrid position).The selection, respects Legislative Decree 198/2006 and is open to candidates of any orientation or expression of gender, sexual orientation, age, ethnicity and religious belief. This announcement isdesigned to respect diversity and inclusiveness.