Manager Labelling And Regulatory Submissions Lazio

Manager Labelling And Regulatory Submissions
Roma
Lazio, Lazio

Social network you want to login/join with: Manager Labelling and Regulatory Submissions, Rome Client: PharmaLex Location: Rome Job Category: Other EU work permit required: Yes Job Reference: 9aa481b1bc33 Job Views: 3 Posted: 22. 01. 2025 Expiry Date: 08. 03. 2025 Job Description: Your Job Participation in the preparation, revision, and compilation of informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and non-EU markets, preferably including development of target product/labelling profiles. Manage creation and maintenance of CCDS/CCSI/RSI, in collaboration with relevant departments/expert functions responsible for CCDS section content (e. g. , medical, safety department). Ensure communication to internal/external stakeholders regarding new and updated CCDSs. Escalate deviation and compliance issues to the labelling governance bodies (e. g. , Safety monitoring committee, Global labelling boards) as necessary. Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level. Ensure that regulatory affairs, development consulting, and scientific affairs programs and projects are delivered to high standards. Plan and expedite approval projects using available or client-based software tools including databases and document management systems. Provide regulatory expertise to regulatory programs and projects as well as to clients. Offer general guidance (consultancy) to PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities including updates on new trends and/or changes in legislation. Present seminars and lectures on behalf of PharmaLex internally, for customers, and for professional audiences. Create, revise, edit, and maintain regulatory documentation. Engage in professional interaction with clients and Health Authorities. Coordinate project teams with internal/external staff and Regulatory Alliance Partners globally. Participate in strategic regulatory issues including definition of suitable methods of resolution. Provide technical support to business development with a focus on Labeling activities and adjacent areas at the EU level and preferably also on a global level. Your Profile You speak fluent business English or English is your mother tongue; skills in another EU language are preferred. You have preferably completed a degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in science, engineering, or a mathematical domain. You have professional experience in regulatory affairs with a profound track record in labeling activities for innovator drugs on a global level. You bring experience in handling marketing authorizations and their lifecycle management. You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region. You have an affinity for databases, labeling software tools, and project management software, and are used to closely monitor and adhere to timelines. You are a team player, communicative, conscientious, accurate, and responsible. Confident with MS Excel and MS Word as well as databases and document management systems. We offer Diverse and challenging job. Open and appreciative corporate culture. Flexible working hours based on trust. Possibility to work reduced number of hours. Possibility to work from home. Continuous development opportunities through knowledge and experience as well as training. J-18808-Ljbffr