Elena Monaco
Regulatory Affairs Specialist @Alfasigma
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WORK HISTORY
Regulatory Affairs Specialist @Alfasigma
Roma, IT
Pharma Products Italy•Submissions and monitoring of regulatory applications through the main European and national portals.•Regulatory activities related to the lifecycle management of medicinal products (transfer of marketing authorization, registrations, variations, and renewals for National, Mutual Recognition, Decentralized, and Centralized procedures in compliance with EU and local requirements)•Interaction with Competent Authorities, including AIFA and the Ministry of Health.•Liaising with cross-functional teams to ensure regulatory compliance across departments.•Knowledge of current legislation updates concerning Medicinal Products•e-CTD dossier preparation, publishing, submission tracking and regulatory information management (VeeVa RIM).•Management of communications to Competent Authorities regarding medicinal product shortages, ensuring timely and compliant reporting.•Review of promotional materials to guarantee compliance with pharmaceutical advertising regulation
EDUCATION
Sapienza Università di Roma
Laurea Magistrale, Biotecnologie farmaceutiche
Sapienza Università di Roma
Bachelor's degree, Biotechnology
Università Cattolica del Sacro Cuore
Corso di Master Universitario di 2° livello-CMU2, Sviluppo preclinico e clinico del farmaco: aspetti tecnico scientifici regolatori ed etici
ABOUT ELENA MONACO
Passionate about regulatory compliance and pharmaceutical development, with a background in both academia and industry. Currently serving as a Regulatory Affairs Specialist at Alfasigma, I specialize in ensuring compliance with EU and Italian regulations for pharmaceutical products. Key responsibilities include formulating regulatory strategies, preparing documentation in CTD and eCTD formats, and managing regulatory procedures to support product lifecycle management.Prior to this role, I honed my research skills during a Master Thesis Trainee position at the National Institute of Health (ISS). Here, I investigated the toxic effects of emerging hormonal therapies using rat models, focusing on applications in gender affirmation treatments. This experience equipped me with a comprehensive understanding of rodent handling, experimentation, and ethical considerations in animal research.My academic journey includes a Master\'s degree in Pharmaceutical Biotechnology from Sapienza Università di Roma, where I graduated with top honors. I recently pursued a second-level Master\'s degree in Preclinical and Clinical Drug Development at Università Cattolica del Sacro Cuore, I\'m expanding my expertise in drug discovery, clinical trials, regulatory affairs, and pharmacoeconomics.Driven by a commitment to excellence and compliance, I am dedicated to contributing to the advancement of pharmaceutical research and development, with a focus on ensuring safe and effective therapies for patients worldwide.
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