Requirements: English
Company: Leo Pharma
Region: Rome , Lazio
Company DescriptionAt LEO Pharma, we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics in a largely unexplored therapeutic area. We draw inspiration from people living with skin diseases daily, aiming to address their greatest health needs, advance medical dermatology, and support them in living fulfilling lives. As a purpose-driven company, we measure high performance not only by sales but also by the positive impact we create for healthcare professionals and patients. These aspirations reflect our ongoing pursuit of the worlds best talent.Job DescriptionThe role will ensure local regulatory strategic insights and optimal pathways to drug development, including relevant local regulatory intelligence. It will also involve securing essential interfaces with Regional Leads.ResponsibilitiesExecute specialized projects or activities aligned with overall functional objectives.Maintain existing Clinical Trial and Marketing Authorizations where applicable.Submit Clinical Trial Applications for new protocols and amendments via the local web portal, complying with national requirements.Work in accordance with regulatory systems and processes.Handle Legal, Medical & Regulatory activities for promotional and non-promotional marketing materials under supervision.Foster constructive regulatory collaboration with Commercial, Customer Order Management, Global Product Supply, Global Quality Assurance, Pharmacovigilance, Global Public Affairs, Marketing Compliance, and other key areas.Prepare and maintain texts for product packaging, patient leaflets, SmPCs, etc.Engage in regulatory intelligence and networking, including contact with Regulatory Authorities, Trade Associations, and other pharmaceutical companies, with attendance at external meetings.Review new legislation, share relevant information with stakeholders, and monitor its impact.Create local regulatory documents in eDOC LEO, as applicable.Perform administrative responsibilities following LEO Pharma QMS processes and procedures.Assess new and revised regulatory legislation and guidelines relevant to the role.Communicate new requirements with potential global impact to the Regulatory Intelligence Department and stakeholders.Participate in ad hoc regulatory projects with some supervision.Support constructive relationships with local Regulatory Authorities and trade associations.Communicate effectively internally and externally on complex matters.Participate actively in Regulatory Affairs working groups.Develop proposals to improve existing processes and practices.Deputize for senior team members as needed, including representing LRA at global and external meetings.QualificationsDegree in Life Sciences, Pharmacy, or equivalent experience.Relevant experience in Regulatory Affairs with a good understanding of the drug development process and lifecycle management.Familiarity with submission portals, electronic document management systems, and IT tools such as Veeva, eRIMS, eDOC, MyDoc, MS Word, Excel, PowerPoint, Visio, Lotus Notes, and Outlook.Stay updated on scientific and regulatory developments.Additional skills include accountability, proactive attitude, cross-functional collaboration, effective communication, decision-making, attention to detail, and resilience.#J-18808-Ljbffr